RecallRadar

FDA Device recall Z-2916-2018

Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, -3.25 Power

On 2018-08-29 the FDA classified a Class II recall of Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, -3.25 Power by Johnson And Johnson Vision Care, citing johnson and Johnson Vision Care received a number of reports of a partially formed contact lens, which appears to the customer or consumer as visibly smaller in diameter, thicker/….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2916-2018
ClassificationClass II
Statusterminated
Initiated2018-07-23
Published2018-08-29
Last updated2026-09-13 11:54 UTC
CompanyJohnson And Johnson Vision Care
DistributionUS

Product

Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, -3.25 Power. Master Lot, containing 12 split lots, repackaged in 30 and 90-packs . Intended for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.

Reason

Johnson and Johnson Vision Care received a number of reports of a partially formed contact lens, which appears to the customer or consumer as visibly smaller in diameter, thicker/stiffer to the touch and more darkly tinted blue than the normal contact lens.

Identifiers

code_info
Master Lot Number 516191. 90 Pack Lot Number (US, PR, Canada, Barbados) 5165915104 which contains 30 pack lot numbers:…Master Lot Number 516191. 90 Pack Lot Number (US, PR, Canada, Barbados) 5165915104 which contains 30 pack lot numbers: 5165910104, 5165910105, 5165910106, 5165910107, 5165910108, 5165910109. 90 Pack Lot Number (Japan) 5165915110 which contains 30 pack lot numbers: 5165910110, 5165910111, 5165910112. 90 Pack Lot Number (Korea and Japan) 5165915101 which contains 30 pack lot numbers: 5165910101, 5165910102, 5165910103. Unique Device Identifier (UDI): 733905577215, 733905615078, and 733905888472.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2916-2018%22

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