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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80837

13 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 08, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Bausch & Lomb Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

13 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 13

Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.

Z-3265-2018
Recall number
Z-3265-2018
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bausch & Lomb Inc
Quantity
33 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The back cap separates from the body of the vitrectomy cutter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The back cap separates from the body of the vitrectomy cutter.

Code information

Lot numbers V9400, exp. 11/6/2018; W1439, exp. 8/19/2019; and W1467, exp. 8/26/2019, UDI 00757770058891.

Distribution pattern

Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.

device · product 2 of 13

Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF SE5420M (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper.

Z-3266-2018
Recall number
Z-3266-2018
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bausch & Lomb Inc
Quantity
16 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The back cap separates from the body of the vitrectomy cutter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The back cap separates from the body of the vitrectomy cutter.

Code information

Lot numbers W0861, Exp. 6/4/2019, and W1115, exp. 7/5/2019, UDI 00757770059447.

Distribution pattern

Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.

device · product 3 of 13

Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REF SE5420W (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper.

Z-3267-2018
Recall number
Z-3267-2018
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bausch & Lomb Inc
Quantity
9 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The back cap separates from the body of the vitrectomy cutter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The back cap separates from the body of the vitrectomy cutter.

Code information

Lot numbers W0862, exp. 6/4/2019, Exp. 9/24/2019, UDI 00757770059522.

Distribution pattern

Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.

device · product 4 of 13

Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper.

Z-3268-2018
Recall number
Z-3268-2018
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bausch & Lomb Inc
Quantity
103.33 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The back cap separates from the body of the vitrectomy cutter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The back cap separates from the body of the vitrectomy cutter.

Code information

Lot numbers V9300, exp. 10/17/2018; V9807, exp. 1/7/2019; W0019, exp. 2/5/2019; and W1468, exp. 8/26/2019, UDI 00757770058907.

Distribution pattern

Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.

device · product 5 of 13

Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite Pack, REF SE5423MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.

Z-3269-2018
Recall number
Z-3269-2018
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bausch & Lomb Inc
Quantity
19.33 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The back cap separates from the body of the vitrectomy cutter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The back cap separates from the body of the vitrectomy cutter.

Code information

Lot numbers W0147, exp. 2/26/2019; W0781, exp. 5/11/2019; W0870, exp. 6/4/2019; and W1721, 10/1/2019, UDI 00757770059423.

Distribution pattern

Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.

device · product 6 of 13

Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wide-Field Elite Pack, REF SE5423WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.

Z-3270-2018
Recall number
Z-3270-2018
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bausch & Lomb Inc
Quantity
94 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The back cap separates from the body of the vitrectomy cutter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The back cap separates from the body of the vitrectomy cutter.

Code information

Lot numbers W0189, exp. 2/28/2019; W0148, exp. 2/26/2019; W0782, exp. 5/11/2019; W0871, exp. 6/4/2019; W1002, exp. 6/23/2019; W1223, exp. 7/21/2019; and W1259, exp. 7/27/2019, UDI 00757770059508.

Distribution pattern

Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.

device · product 7 of 13

Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.

Z-3271-2018
Recall number
Z-3271-2018
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bausch & Lomb Inc
Quantity
131 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The back cap separates from the body of the vitrectomy cutter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The back cap separates from the body of the vitrectomy cutter.

Code information

Lot numbers V9301, exp. 10/17/2018; V9401, exp. 11/6/2018; V9708, exp. 12/4/2018; W1019, exp. 6/23/2019; and W1675, exp. 9/24/2019, UDI 00757770058914.

Distribution pattern

Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.

device · product 8 of 13

Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Field Elite Pack, REF SE5425MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.

Z-3272-2018
Recall number
Z-3272-2018
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bausch & Lomb Inc
Quantity
67 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The back cap separates from the body of the vitrectomy cutter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The back cap separates from the body of the vitrectomy cutter.

Code information

Lot numbers W0149, exp. 2/26/2019; W0190, exp. 2/28/2019; W0785, exp. 5/11/2019; W0874, exp. 6/4/2019; and W1108, exp. 7/5/2019, UDI 00757770059430.

Distribution pattern

Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.

device · product 9 of 13

Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wide-Field Elite Pack, REF SE5425WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.

Z-3273-2018
Recall number
Z-3273-2018
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bausch & Lomb Inc
Quantity
97.33 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The back cap separates from the body of the vitrectomy cutter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The back cap separates from the body of the vitrectomy cutter.

Code information

Lot numbers W0157, exp. 2/26/2019; W0191, exp. 2/28/2019; W0786, exp. 5/11/2019; W1116, exp. 7/5/2019; and W1225, exp. 7/21/2019, UDI 00757770059485.

Distribution pattern

Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.

device · product 10 of 13

Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-Field Elite Pack, REF SE5523MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.

Z-3274-2018
Recall number
Z-3274-2018
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bausch & Lomb Inc
Quantity
39.33 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The back cap separates from the body of the vitrectomy cutter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The back cap separates from the body of the vitrectomy cutter.

Code information

Lot numbers W0783, exp. 5/11/2019; W0872, exp 6/4/2019; W1107, exp. 7/5/2019; and W1224, exp. 7/21/2019; UDI 00757770059454.

Distribution pattern

Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.

device · product 11 of 13

Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide-Field Elite Pack, REF SE5523WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.

Z-3275-2018
Recall number
Z-3275-2018
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bausch & Lomb Inc
Quantity
15.33 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The back cap separates from the body of the vitrectomy cutter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The back cap separates from the body of the vitrectomy cutter.

Code information

Lot numbers W0784, exp, 5/11/2019, and W0873, exp. 6/4/2019, UDI 00757770059690.

Distribution pattern

Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.

device · product 12 of 13

Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-Field Elite Pack, REF SE5525MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.

Z-3276-2018
Recall number
Z-3276-2018
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bausch & Lomb Inc
Quantity
66 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The back cap separates from the body of the vitrectomy cutter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The back cap separates from the body of the vitrectomy cutter.

Code information

Lot numbers W0787, exp. 5/11/2019; W0888, exp. 6/4/2019; W1003, exp. 6/23/2019; and W1129, exp 7/6/2019, UDI 00757770059430.

Distribution pattern

Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.

device · product 13 of 13

Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Field Elite Pack, REF SE5525WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.

Z-3277-2018
Recall number
Z-3277-2018
Initiated
August 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bausch & Lomb Inc
Quantity
10 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The back cap separates from the body of the vitrectomy cutter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The back cap separates from the body of the vitrectomy cutter.

Code information

Lot number W0788, exp. 5/11/2019, UDI 00757770059683.

Distribution pattern

Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.