YAG LASER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-01-06 for YAG LASER * manufactured by *.

Event Text Entries

[307613] In 2001, pt had successful elective surgery to replace the lens in each eye to correct severe farsightedness and astigmatism. A year later a cloudiness developed in left eye, which dr described as a secondary membrane and said it was very common. A procedure using the yag laser was performed and pt had a follow-up visit on 5/17/2002. While on vacation in late 7/2002, pt noticed a discoloration on the outer rim of left eye. Dr diagnosed this as pterygium. When pt asked if this was caused by the yag laser, he assured pt that it was due to sun exposure. Pt doesn't play golf or tennis, and doesn't sun bathe or work outdoors, so pt's not exposed to the sun enough to cause this kind of damage. Pt also wears sunglasses when they are in the sun. Pt would like to know if there are reports or research about the yag laser causing a pterygium-like growth.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1027193
• MDR Report Key: 436905
• Date Received: 2003-01-06
• Date of Report: 2003-01-06
• Date of Event: 2002-04-16
• Date Added to Maude: 2003-01-13
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: YAG LASER
• Generic Name: LASER FOR TREATMENT OF SECONDARY MEMBRANE FOLLOWING CATARACT
• Product Code: LOI
• Date Received: 2003-01-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 425838
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-01-06