UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-01-31 for UNK * manufactured by *.

Event Text Entries

[236419] Phaco machine malfunctioned during cataract surgery by dr. Broke and impaled "i/a" needle in left eye. Left the needle in eye and did not tell rptr. Dr performed what was supposed to be a yag capsulotomy. In fact, dr used the laser to cut and melt the haptics of rptr's iol. Five holes made in iris and iol destroyed. Another dr did corrective eye surgery. Dr never informed rptr about the needle and melted haptics. Dr has sworn under oath that rptr did not have any foreign objects in eye. Dr introduced an add'l piece of metal, calling it a splint to hold things together. Rptr discovered the needle and melted haptics early 2001 and current dr has confirmed the items, but rptr suspects that dr is not documenting the objects in rptr's medical record. Rptr has today, in left eye, an "i/a" needle, in three pieces, two embedded in cilliary muscle, and one piece with an attached o-ring, extending from the posterior chamber into the vitreous chamber. Rptr has melted haptics embedded at several locations of cilliary muscle. There is a rather concentrated cover-up. Evidence is hard to come by for that reason, but there is some and of course rptr still has all the evidence in eye. Rptr will submit eye for examination by any one the fda might select, should the fda wish to investigate this matter.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1020976
• MDR Report Key: 314555
• Date Received: 2001-01-31
• Date of Report: 2001-01-31
• Date of Event: 1996-04-22
• Date Added to Maude: 2001-02-06
• 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 Sequence Number: 1

• Brand Name: UNK
• Generic Name: PHACO MACHINE
• Product Code: HQC
• Date Received: 2001-01-31
• 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: 304215
• Manufacturer: *
• Manufacturer Address: * * *

Device Sequence Number: 2

• Brand Name: UNK
• Generic Name: YAG LASER MACHINE
• Product Code: LXS
• Date Received: 2001-01-31
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 304217
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2001-01-31