Purepoint 8065752987Recalls & reported problems
Alcon Laboratories, Inc. · Purepoint Laser · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380657529872), received between May 2, 2024 and May 15, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Defective Component” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Component1
- Energy Spectrum Incorrect1
- Failure to Fire1
- Loss of Power1
Patient problems
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2024Loss of Power; Loss of Power
A NON HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC LASER HAD LOW LASER POWER FROM OPHTHALMOSCOPE. PROCEDURE AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 19318584 ↗InjuryMay 8, 2024Energy Spectrum Incorrect; Energy Spectrum Incorrect
A CUSTOMER REPORTED THAT THE EYE WAS GETTING FLASHED, GREEN LASER LIGHT COMING THROUGH IN THE TOP CORNER. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE DETAILS OF PATIENT IMPACT WAS NOT REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 19268164 ↗MalfunctionMay 2, 2024Defective Component; Failure to Fire; Defective Component; Failure to Fire
A CUSTOMER REPORTED THAT AN OPHTHALMIC LASER HAD NO LASER FIRING AND ISSUE WITH HEADPIECE WHICH AXEL WAS BROKEN. DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 19228327 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.