PUREPOINTRecalls & reported problems across all models
Alcon Laboratories, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 245
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 2 models of PUREPOINT by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 245 adverse event reports in the FDA's MAUDE database, received between Mar 2, 2021 and Apr 1, 2026 — classified as 5 injuries, 240 malfunctions.
The most frequently reported specific device problem is “Energy Output Problem” (146 reports).
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
Reports received per month, all models
Most reported PUREPOINT problems
Device problems
- Energy Output Problem146
- Failure to Fire34
- Failure to Deliver Energy20
- Unexpected Shutdown12
- Appropriate Device Problem Term/Code Not Available9
- Intermittent Energy Output9
- Loss of Power6
- No Display/Image5
Patient problems
- No Clinical Signs, Symptoms or Conditions190
- Insufficient Information51
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Eye Pain2
- Blurred Vision1
- Eye Injury1
- Retinal Injury1
PUREPOINT models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PUREPOINT 8065750597SOURCE, ABORTION UNIT, VACUUM242 reports
- Purepoint 8065752987Laser, ophthalmic3 reports
Recent PUREPOINT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2026Failure to Fire
A CUSTOMER REPORTED THAT AN OPHTHALMIC LASER CONSOLE EXHIBITED LOW OR POOR LASER POWER. THE DETAILS OF THE PROCEDURE AND PATIENT IMPACT HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24754833 ↗MalfunctionMar 20, 2026Failure to Fire
A CUSTOMER REPORTED THAT OPHTHALMIC LASER EXHIBITED LOW POWER FROM THE SLIT LAMP. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24647923 ↗MalfunctionMar 9, 2026Failure to Fire
A CUSTOMER REPORTED THAT AN OPHTHALMIC LASER SYSTEM EXHIBITED LOW POWER. PROCEDURE DETAILS AND SURGERY COMPLETION DETAILS ARE UNKNOWN. INFORMATION REGARDING PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24545243 ↗MalfunctionMar 3, 2026Failure to Fire
A CUSTOMER REPORTED THAT AN OPHTHALMIC LASER HAD LOW POWER. DETAILS OF PROCEDURE AND PATIENT IMPACT WERE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24494319 ↗MalfunctionFeb 27, 2026Display or Visual Feedback Problem
ADDITIONAL INFORMATION RECEIVED THAT BEFORE THE VITRECTOMY SURGERY THE REPORTED EVENT WAS REPORTED. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT WITHOUT ANY PATIENT IMPACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24468213 ↗MalfunctionFeb 19, 2026Failure to Fire
A CUSTOMER REPORTED THAT DURING THE OPHTHALMIC LASER CONSOLE EXHIBITED LOW LASER POWER. THE PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24386078 ↗MalfunctionNov 26, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback
A CUSTOMER REPORTED THAT AN OPHTHALMIC LASER NOT PRODUCING ANY LASER SOUND. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TO DATE.
Patient problems: Insufficient Information
MAUDE report 23655584 ↗MalfunctionNov 14, 2025Failure to Fire; Failure to Fire
A CUSTOMER REPORTED THAT IN AN OPHTHALMIC LASER SYSTEM THE LASER ENERGY WAS LOW ON PORT TWO, THE PROCEDURE WAS PERFORMED WITH PORT ONE. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 23553960 ↗MalfunctionOct 27, 2025Failure to Fire; Failure to Fire
A CUSTOMER REPORTED THAT AN OPHTHALMIC LASER EXHIBITED LOW POWER. THE PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TO DATE.
Patient problems: Insufficient Information
MAUDE report 23388735 ↗MalfunctionOct 16, 2025Failure to Fire; Failure to Fire
A CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING SYSTEM EXHIBITED LOW LASER OUTPUT. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 23308233 ↗MalfunctionSep 16, 2025Failure to Fire; Failure to Fire
A CUSTOMER REPORTED THAT IN AN OPHTHALMIC SYSTEM, LASER DID NOT FIRE. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 23062685 ↗MalfunctionSep 11, 2025Failure to Fire; Failure to Fire
A CUSTOMER REPORTED THAT AN OPHTHALMIC LASER WAS MISALIGNED WITH THE SLIT LAMP. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. NO PATIENT HARM HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23025873 ↗MalfunctionSep 10, 2025No Display/Image; No Display/Image
A CUSTOMER REPORTED THAT AN OPHTHALMIC LASER FAILED TO BOOT AND SYSTEM MESSAGE (SM) WAS NOT DISPLAYED. PROCEDURE DETAILS AND PATIENT HARM WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 23016337 ↗MalfunctionSep 9, 2025Failure to Fire; Failure to Fire
A CUSTOMER REPORTED THAT AN OPTHALMIC OPERATING CONSOLE EMITTED LOW LASER ENERGY. THE DETAILS OF PROCEDURE AND PATIENT IMPACT HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23008531 ↗MalfunctionAug 12, 2025Failure to Fire; Failure to Fire
A CUSTOMER REPORTED THAT AN OPHTHALMIC LASER EXHIBITED WITH LOW LASER POWER WHEN USING WITH SLIT LAMP. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 22781750 ↗
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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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