* RCS300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-04-18 for * RCS300 manufactured by Refract.

Event Text Entries

[445034] I went to the ophthalmologist to have ck procedure done on my right eye. I had 20/50 vision prior to the procedure. I was told that i might have some slight blurred vision immediately post procedure, but that this would resolve within 3 days. It has been 5 months and i remain legally blind in the right eye, by definition. I have gotten a 2nd opinion by an ophthalmologist at another hosp, who states that he feels that my current visual deficit is permanent. The surgery itself appears to have been performed correctly, but the degree of "correction" was well beyond anticipated or desired. The performing surgeon states that he does not know what happened; he has never seen this before. I put in an inital report, but did not have device info at the time. I am now wondering if there could be a device problem which resulted in mis-measurement or some other problem with the surgery.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1038732
• MDR Report Key: 707863
• Date Received: 2006-04-18
• Date of Report: 2006-04-18
• Date of Event: 2005-11-11
• Date Added to Maude: 2006-05-05
• 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: 3
• 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: *
• Generic Name: VIEWPOINT CK SYSTEM
• Product Code: HQR
• Date Received: 2006-04-18
• Model Number: RCS300
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 696914
• Manufacturer: REFRACT
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2006-04-18