ORTHOKERATOLOGY LENS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-09-15 for ORTHOKERATOLOGY LENS * manufactured by Unk.

Event Text Entries

[158242] 5/98 eye dr prescribed orthokeratology contact lens (ok lens). Instructed pt to wear lenses every night and he said it would correct the "short sight" permanently. On 8/15/99, swelling of right eye, burning and tingling when pt looked at the light. Pt went to the dr's office and he said swelling was caused by a viral infection. He advised pt to encourage fluid intake and that she could continue to wear ok lens at night. Pt stopped wearing ok lens on right eye, but continued to wear ok lens on left eye. On 8/29, same condition happened on the left eye. Now the short sight returns when not wearing the ok lens.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1017216
• MDR Report Key: 241632
• Date Received: 1999-09-15
• Date of Report: 1999-09-15
• Date of Event: 1999-08-15
• Date Added to Maude: 1999-09-24
• 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: ORTHOKERATOLOGY LENS
• Generic Name: ORTHOKERATOLOGY LENS
• Product Code: MUW
• Date Received: 1999-09-15
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 234109
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-09-15