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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRK LASER

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PRK LASER Back to Search Results
Event Date 10/15/1992
Event Type  Injury  
Event Description

In 1992, i lost my vision after refractive surgery - rk. In early october i had gone to a "free" seminar to gather info before i saw a dr. I had pre-existing scar tissue on my left eye but dr said "no problem", and we proceeded with bilateral refractive surgery. I did not have good vision from the start. I was told that "things have not settled down yet. We can always perform an enhancement. " i struggled with my duties at home and work. In 1993, i went to another city to see another dr -a referral from dr(first)-. He performed a prk on my left eye with later plans to surgically improve the right eye. At that time second dr told me that dr(first) made the cuts in my eyes too deep and too long. My left eye now had vision worse than pre-prk and was covered with scar tissue from the laser. In 1995, i went on medical leave from my surgical nursing position and had a corneal transplant. During that year, i filed for disability retirement. In 1996, i went to jury trial -case, medical malpractice. I was the victim made to look like a perpetrator. We lost the case and threw ourselves into debt. Dr(first) told me i was a good candidate for refractive surgery, that i would have good results and could throw away my glasses. He never told me there was no turning back from this surgery. He never mentioned the star burst, night blindness, double vision or painful dry eye. He never mentioned that i would not be able to care for my three children. I live the nightmare every day and cringe when i see the same advertising today as when i had my disastrous eye surgery. Dates of use: 1992 - 1993. Diagnosis or reason for use: rk cutting device and laser for prk procedure.

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Type of DevicePRK LASER
MDR Report Key1039140
Report NumberMW5006750
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/06/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/06/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes

Date Received: 05/06/2008 Patient Sequence Number: 1