PUREPOINT 8065750597Recalls & reported problems
Alcon Laboratories, Inc. · PUREPOINT LASER SYSTEM · Class 2
All models of PUREPOINT (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon PurePoint ophthalmic laser system has 248 reports on file, with no deaths and 4 injuries. Many describe low or poor laser output, and others describe the laser failing to fire or shutting down unexpectedly, with reports often lacking procedure details. A few patients mention eye pain or blurred vision. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 242
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 242 adverse event reports that list this exact device (DI 00380657505975), received between Mar 2, 2021 and Apr 1, 2026 — classified as 4 injuries, 238 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Energy Output Problem146
- Failure to Fire33
- Failure to Deliver Energy20
- Unexpected Shutdown12
- Appropriate Device Problem Term/Code Not Available9
- Intermittent Energy Output9
- Loss of Power5
- No Display/Image5
Patient problems
- No Clinical Signs, Symptoms or Conditions189
- Insufficient Information49
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Eye Pain2
- Blurred Vision1
- Eye Injury1
- Retinal Injury1
Recent adverse event reports
The 25 most recent of 242 reports, 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 ↗MalfunctionJul 15, 2025Failure to Fire; Unexpected Shutdown; Failure to Fire; Unexpected Shutdown
A CUSTOMER REPORTED THAT THE OPHTHALMIC LASER SYSTEM SHUT DOWN DURING LASERPEXY WITH BIO (BINOCULAR INDIRECT OPHTHALMOSCOPY) PROCEDURE. PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 22507197 ↗MalfunctionMay 23, 2025Failure to Fire; Failure to Fire
A CUSTOMER REPORTED THAT AN OPHTHALMIC LASER HAD NO LASER UPTAKE. DETAILS OF PROCEDURE WAS NOT REPORTED. NO IMPACT ON PATIENT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 22077916 ↗MalfunctionMay 6, 2025Failure to Fire; Failure to Fire
A CUSTOMER REPORTED THAT AN OPHTHALMIC LASER DID NOT BURN. 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 21967044 ↗MalfunctionMay 2, 2025Failure to Fire; Failure to Fire
A CUSTOMER REPORTED THAT AN OPHTHALMIC LASER HAD LOW ENERGY AND INTERMITTENT SHUTDOWN OF INDIRECT OPHTHALMOSCOPE LIGHT. DETAILS OF PROCEDURE WAS NOT PROVIDED. NO IMPACT ON PATIENT WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21950542 ↗MalfunctionApr 23, 2025Energy Output Problem; Energy Output Problem
A CUSTOMER REPORTED THAT DURING RETINOPATHY SURGERY, AN OPHTHALMIC LASER HAD LOW OUTPUT DELIVERY. THE SURGERY WAS COMPLETED AFTER REPLACING CORE MODULE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21890846 ↗MalfunctionApr 17, 2025Failure to Fire; Failure to Fire
A CUSTOMER REPORTED THAT AN OPHTHALMIC LASER HAD ISSUES WITH LOW LASER POWER. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 21857006 ↗MalfunctionMar 7, 2025Energy Output Problem; Failure to Fire; Energy Output Problem; Failure to Fire
ADDITIONAL INFORMATION RECEIVED STATING THAT AFTER THE START OF SURGERY WHILE ATTEMPTING TO APPLY THE OPHTHALMIC LASER TO THE PATIENT, IT DID NOT WORK AND THE PROCEDURE COULD NOT BE PERFORMED. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21546101 ↗MalfunctionMar 6, 2025Failure to Fire; Failure to Fire
A CUSTOMER REPORTED THAT THE OPHTHALMIC SYSTEM HAD INTERMITTENT LASER ISSUE. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21535420 ↗MalfunctionMar 4, 2025Failure to Deliver Energy; Failure to Deliver Energy
A CUSTOMER REPORTED THAT AN OPHTHALMIC LASER HAD LOW POWER AND ENERGY DURING THE UNKNOWN TIMING OF THE SURGERY. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21513165 ↗MalfunctionFeb 26, 2025Energy Output Problem; Energy Output Problem
A CUSTOMER REPORTED THAT IN AN OPHTHALMIC SYSTEM POWER WAS NOT STABLE. 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 21466219 ↗
Other SOURCE, ABORTION UNIT, VACUUM devices
- CONSTELLATION 8065751450Alcon Laboratories, Inc. · SOURCE, ABORTION UNIT, VACUUM9 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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