OPTI-FREE REPLENISHRecalls & reported problems across all models

We found 3 models of OPTI-FREE REPLENISH by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Apr 16, 2024 and Apr 16, 2024 — classified as 1 injury.

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

OPTI-FREE REPLENISH recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 25, 2022Open, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1590-2022 · Root cause: Environmental control · names 3 of these models · Recall details · FDA record ↗

Most reported OPTI-FREE REPLENISH problems

OPTI-FREE REPLENISH models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• OPTI-FREE REPLENISH OPTI-FREE REPLENISH 10oz

  Accessories, soft lens products
  1 recall1 report
• OPTI-FREE REPLENISH OPTI-FREE REPLENISH 4oz

  Accessories, soft lens products
  1 recall0 reports
• OPTI-FREE REPLENISH OPTI-FREE REPLENISH 2oz

  Accessories, soft lens products
  1 recall0 reports

Recent OPTI-FREE REPLENISH adverse event reports

The 1 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL ON BEHALF OF CUSTOMER REPORTED THAT CONSUMER EXPERIENCED EYE REDNESS AND DEVELOPED CORNEAL ULCER IN RIGHT EYE. THE CONSUMER ALSO HAD EYE PAIN AND EYE WAS BOTHERING LIKE A SHARP NEEDLE STABBING. THE CONSUMER SOUGHT MEDICAL ATTENTION. THE CONSUMER WAS TREATED WITH MOXIFLOXACIN 0.5% OPHTHALMIC SOLUTION 3ML (1 DROP 6 TIMES A DAY). THE CURRENT STATUS OF THE CONSUMER¿S EYE IS RESOLVED AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Corneal Ulcer; Eye Pain; Foreign Body Sensation in Eye; Red Eye(s)

  MAUDE report 19119020 ↗

Other Alcon Laboratories, Inc. products

• Clareon1,142 models · 8,100 reports · 1 recall
• Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
• Constellation13 models · 2,176 reports · 4 recalls
• CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
• Centurion5 models · 1,967 reports
• ACRYSOF353 models · 1,890 reports
• AcrySof UltraSert102 models · 1,467 reports · 1 recall
• MONARCH III2 models · 1,380 reports · 1 recall