MAUDE Adverse Event Report: LENSAR, INC. LENSAR LASER; OPHTHALMIC FEMTOSECOND LASER

Device Problems Defective Device (2588); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Corneal Edema (1791); Retinal Injury (2048); Visual Impairment (2138)

Event Date 03/15/2022

Event Type  Injury  

Event Description

I recently had eye surgery in (b)(6) 2022 perform by dr.(b)(6).The surgery was performed at the (b)(6).The laser equipment utilized for the surgery used a suction cup that exposes the eye to the laser.During the surgery the suction cup which applies a vacuum on the eye failed 3xs.The manager of this clinic (b)(6) admitted to the fact this equipment had failed multiple times and several surges had to be aborted and the patients reimbursed.This auxiliary equipment has caused retina damage and ectasia (bulging if the cornea).The damage has been confirmed by (b)(6).My eyesight is distorted and a major surgery is required to correct my eyesight.This would put me at a risk of going blind.Several doctors have diagnosed a retina pseudo hole.The clinic where the surgery was performed, has admitted to the fact this equipment has malfunction and some surgeries had to be aborted.The lesnar suction cup since my surgery has been replaced according to the surgery manager.I claim that this device damaged my retina and i am at risk of having to retire early.I am a mechanical engineer for a large oil & gas firm (b)(6).I am requesting that an investigation be conducted to determine why this equipment was allowed to be used when the clinic and the physicians new the suction cup was faulty.I would like to receive the results of this inquiry and serial no., make and model of the laser.I feel that dr.(b)(6) and the clinic is attempting a cover up this defective equipment and many patients may have experienced to their eye as well.Thank you in advance for looking into this matter.Sincerely, (b)(6).This was not a test.It was a device that was used to correct an astigmatism.Reference report #mw5117540 #mw5117541.

• Brand Name: LENSAR LASER
• Type of Device: OPHTHALMIC FEMTOSECOND LASER
• Manufacturer (Section D): LENSAR, INC.
• MDR Report Key: 16939420
• MDR Text Key: 315389600
• Report Number: MW5117542
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: SYMBICORT, ALBUTEROL, BETAXOLOL, SIMBRINZA, TYRVAYA.; SYSTANE.
• Patient Outcome(s): Disability
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American