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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90661

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

Open FDA event record

Event summary

Timeline bucket
July 08, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Oculus Optikgeraete GMBH

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

3 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 3

Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.

Z-1672-2022
Recall number
Z-1672-2022
Initiated
July 08, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Oculus Optikgeraete GMBH
Quantity
21 systems with affected software

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs

Code information

Software version: 1.26r26 and 1.26r27 Model Number: 70020 UDI-DI Code: 04049584025357 Serial Numbers: 70020 0111 0201 70020 0211 0201 70020 0311 0211 70020 0711 1230 70020 1211 0201 70020 1321 1211 70020 2411 0211 70020 2911 1250 70020 3511 0211 70020 3801 0230 70020 4701 0210 70020 4811 1250 70020 5411 0211 70020 5701 0210 70020 6611 1230 70020 6621 1211 70020 7011 0201 70020 7511 1230 70020 8021 1290 70020 8701 0210 70020 9011 0201

Distribution pattern

U.S.: AL, AR, AZ, CAQ, CO, CT, FL, GA, HI, IA, ID, IL, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, and WY O.U.S.: N/A

device · product 2 of 3

Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.

Z-1673-2022
Recall number
Z-1673-2022
Initiated
July 08, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Oculus Optikgeraete GMBH
Quantity
92 systems with affected software

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs

Code information

Software version: 1.26r26 and 1.26r27 Model Number: 70100 UDI-DI Code: 04049584012333 Serial Numbers: 70100 0301 5170 70100 0332 1280 70100 0351 7190 70100 0421 6101 70100 0461 7121 70100 0561 8130 70100 0641 7170 70100 0981 9120 70100 1032 1270 70100 1171 8180 70100 1291 9130 70100 1491 9140 70100 1551 7190 70100 1631 7140 70100 1632 2210 70100 1751 7190 70100 1802 0250 70100 1881 9120 70100 2181 8101 70100 2651 7190 70100 2731 7140 70100 2821 7110 70100 2912 1220 70100 3122 1240 70100 3141 7160 70100 3221 6190 70100 3222 1240 70100 3541 7160 70100 3561 8130 70100 3691 9160 70100 3701 6110 70100 3722 1270 70100 3881 9120 70100 3931 7150 70100 4012 0270 70100 4032 1270 70100 4502 0230 70100 4511 6170 70100 4922 1270 70100 4961 8170 70100 5032 1270 70100 5071 8180 70100 5141 7160 70100 5232 1280 70100 5311 6160 70100 5332 1290 70100 5441 7160 70100 5461 7121 70100 5621 6111 70100 5651 7190 70100 5661 8130 70100 5671 8101 70100 5981 9120 70100 6022 1220 70100 6032 1270 70100 6171 8180 70100 6332 1290 70100 6421 6101 70100 6451 7190 70100 6631 7140 70100 6651 7190 70100 6751 7111 70100 6821 7110 70100 7511 6170 70100 7631 7140 70100 7781 9120 70100 7831 7150 70100 7861 8170 70100 8021 6190 70100 8121 6190 70100 8212 0290 70100 8332 1290 70100 8511 6170 70100 8512 0211 70100 8611 6170 70100 8731 7150 70100 8791 9170 70100 8822 1270 70100 8891 9170 70100 9081 8101 70100 9132 1280 70100 9171 8180 70100 9221 6101 70100 9231 7130 70100 9332 1290 70100 9361 7121 70100 9471 8101 70100 9822 1270 70100 9881 9120 70100 9911 6190 70100 9912 1220 70100 9931 7150

Distribution pattern

U.S.: AL, AR, AZ, CAQ, CO, CT, FL, GA, HI, IA, ID, IL, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, and WY O.U.S.: N/A

device · product 3 of 3

Pentacam HR REF 70900. Used to image the anterior segment of the eye.

Z-1674-2022
Recall number
Z-1674-2022
Initiated
July 08, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Oculus Optikgeraete GMBH
Quantity
19 systems with affected software

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs

Code information

Software version: 1.26r26 and 1.26r27 Model Number: 70900 UDI-DI Code: 04049584000026 Serial Numbers: 70900 0574 8160 70900 0925 0240 70900 0995 2250 70900 1664 8130 70900 1995 2250 70900 3451 7060 70900 3795 2250 70900 3965 1270 70900 4041 7010 70900 4172 2110 70900 4795 2250 70900 6234 7150 70900 7552 1160 70900 7952 1180 70900 8804 6140 70900 8813 3140 70900 9142 0121 70900 9695 2250 70900 9795 2250

Distribution pattern

U.S.: AL, AR, AZ, CAQ, CO, CT, FL, GA, HI, IA, ID, IL, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, and WY O.U.S.: N/A