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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80800

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

Open FDA event record

Event summary

Timeline bucket
July 03, 2018
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Alden Optical

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

2 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 2

Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric); Zenlens Toric-Zenlens FT + MV (Front Toric+Microvault); Zenlens TPC-(Toric Peripheral Curve); Zenlens TPC + FT- (Toric Peripheral Curve + FrontToric) Zenlens TPC + MV- (Toric Peripheral Curve+Microvault). Catalog Number: AOZNT Zenlens Toric - Zenlens contact lenses are indicated for daily wear for the correction of refractive arnetropia (myopia, hyperopia, and astigmatism) in aphakic and nonaphakic persons with non-diseased eyes.

Z-2981-2018
Recall number
Z-2981-2018
Initiated
July 03, 2018
Classification
Class III
Status
Terminated
Recalling firm
Alden Optical
Quantity
36 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Vials labeled for the prescriptions contained incorrect lenses

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Vials labeled for the prescriptions contained incorrect lenses

Code information

Lot Number/ Serial Number B3235820 UDI- (01)00785811435660/(10)18101PTC008 B3237820 UDI- (01)00785811435660/(10)18101PTC008 B3240210 UDI-(01)00785811435660/(10)18101PTC008 B3235420 UDI-(01)00785811435660/(10)18101PTC008 B3238610 UDI-(01)00785811435660/(10)18101PTC008 B3238620 UDI-(01)00785811435660/(10)18111PTC001 B3239510 UDI-(01)00785811435660/(10)18101PTC008 B3239520 UDI-(01)00785811435660/(10)18111PTC001 B3238210 UDI-(01)00785811435660/(10)18101PTC008 B3238220 UDI-(01)00785811435660/(10)18101PTC008 B3240510 UDI-(01)00785811435660/(10)18101PTC008 B3240520 UDI-(01)00785811435660/(10)18101PTC008 B3240720 UDI-(01)00785811435660/(10)18101PTC008 B3238510 UDI-(01)00785811435660/(10)18101PTC008 B3238710 UDI-(01)00785811435660/(10)18101PTC008 B3239620 UDI-(01)00785811435677/(10)18116PTC004 B3238120 UDI-(01)00865576000218/(10)P004732 B3225210 UDI-(01)00785811435660/(10)18101PTC008 B3225410 UDI-(01)00785811435660/(10)18101PTC008 B3225420 UDI-(01)00785811435660/(10)18101PTC008 B3239910 UDI-(01)00865576000201/(10)N003062 B3239920 UDI-(01)00865576000201/(10)N003062 B3236610 UDI-(01)00785811435660/(10)18101PTC008 B3240320 UDI-(01)00785811435660/(10)18101PTC008 B3238410 UDI-(01)00785811435660/(10)18101PTC008 B3238810 UDI-(01)00785811435677/(10)18116PTC004 B3238820 UDI-(01)00785811435677/(10)18116PTC004 B3235620 UDI-(01)00785811435660/(10)18101PTC008 B3240410 UDI-(01)00785811435660/(10)18101PTC008 B3240420 UDI-(01)00785811435660/(10)18101PTC008 B3235220 UDI-(01)00785811435660/(10)18101PTC008 B3237010 UDI-(01)00785811435677/(10)18116PTC004 B3237020 UDI-(01)00785811435677/(10)18116PTC004 B3236110 UDI-(01)00785811435660/(10)18101PTC008 B3236010 UDI-(01)00785811435660/(10)18101PTC008

Distribution pattern

US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT.

device · product 2 of 2

Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC TPC (Toric Peripheral Curve) Zen RC FT (Front Toric Optics) Catalog Number: AOZNT Zenlens Toric - Zenlens contact lenses are indicated for daily wear for the correction of refractive arnetropia (myopia, hyperopia, and astigmatism) in aphakic and nonaphakic persons with non-diseased eyes.

Z-2982-2018
Recall number
Z-2982-2018
Initiated
July 03, 2018
Classification
Class III
Status
Terminated
Recalling firm
Alden Optical
Quantity
4 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Vials labeled for the prescriptions contained incorrect lenses

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Vials labeled for the prescriptions contained incorrect lenses

Code information

B3225920 UDI-(01)00785811435660/(10)18101PTC008 B3237210 UDI-(01)00785811435660/(10)18101PTC008 B3237220 UDI-(01)00785811435660/(10)18101PTC008 B3237910 UDI-(01)00785811435660/(10)18101PTC008

Distribution pattern

US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT.