REFRACTEC *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-30 for REFRACTEC * manufactured by Unk.

Event Text Entries

[383544] Pt ahd conductive keratoplasty done at the eye care center. It created an astigmatism in left eye that was later treated by lasek. Before pt had20/20 vision in that eye. Now pt cannot see without a soft contact lens and glasses both at times. Without correction pt can't drive at night and has severe headaches. Dr tells pt that their eye are fine and that pt just needs to adjust to the blended monovision. Pt finds it strange they didn't tell them about the problem that they and the refractec machine caused for over seven weeks. Pt is retiring from their position because i no longer feel safe with blurred vision and halos.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1034206
• MDR Report Key: 564382
• Date Received: 2004-11-30
• Date of Report: 2004-11-30
• Date of Event: 2004-01-29
• Date Added to Maude: 2005-01-11
• 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: REFRACTEC
• Generic Name: CK PROCEDURE DEVICE
• Product Code: HQR
• Date Received: 2004-11-30
• 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: 554131
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention; 2. Deathisabilit	2004-11-30