CypassRecalls & reported problems across all models

We found 2 models of Cypass 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 10, 2020 and Apr 10, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

2 FDA recall records name at least one of these models by its device identifier.

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

Cypass 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. Aug 28, 2018Class ITerminated

   Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.

   Z-0187-2019 · Root cause: Device Design · Recall details · FDA record ↗

2. Aug 28, 2018Class ITerminated

   Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.

   Z-0185-2019 · Root cause: Device Design · Recall details · FDA record ↗

Most reported Cypass problems

Cypass models

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

• CyPass 8065754003

  Intraocular Pressure Lowering Implant
  1 recall1 report
• Cypass 8065754007

  Intraocular pressure lowering implant
  1 recall0 reports

Recent Cypass adverse event reports

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

• InjuryApr 10, 2020Improper or Incorrect Procedure or Method

  DR (B)(6) CLINIC OF (B)(6) IMPLANTED ALCON CYPASS MICRO STENT IN MY LEFT EYE AFTER HE MISDIAGNOSED ME WITH GLAUCOMA; SUBSEQUENT ASSESSMENTS WITH 3 OTHER OPHTHALMOLOGIST SUBSTANTIATED MALPRACTICE. MEDICAL TESTS AND RESULTS: DR (B)(6). DR (B)(6). YOU HAVE MY PERMISSION TO REQUEST MEDICAL RECORDS. I NEED TO GET THIS IMPLANT REMOVED. IT IS CAUSING PAIN AND VISION LOSS AND RETINAL TEAR AS WELL AS ENDOTHELIAL CELL LOSS. I AM CONCERNED TO AVOID THE NEED FOR A CORNEA TRANSPLANT. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Loss of Vision; Pain; Retinal Tear

  MAUDE report 9952894 ↗

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