COHERENT 9900 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-04-17 for COHERENT 9900 * manufactured by Coherent Med Division.

Event Text Entries

[95298] Pt was scheduled for laser surgery. Yag posterior capsulotomy was attempted on the right eye. Laser malfunctioned; focal point anterior to he-ne beams focal point causing pits in the intraocular lens. Procedure was discontinued to avoid complications. Pt complained of blurred vision following the procedure. Vision later returned to normal.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 163194
• MDR Report Key: 163194
• Date Received: 1998-04-17
• Date of Report: 1998-04-16
• Date of Event: 1998-01-19
• Date Facility Aware: 1998-01-19
• Report Date: 1998-04-16
• Date Reported to Mfgr: 1998-01-21
• Date Added to Maude: 1998-04-21
• Event Key: 0
• Report Source Code: User Facility 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: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: COHERENT
• Generic Name: OPHTHALMIC YAG
• Product Code: LOI
• Date Received: 1998-04-17
• Returned To Mfg: 1998-01-21
• Model Number: 9900
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 158868
• Manufacturer: COHERENT MED DIVISION
• Manufacturer Address: 3270 WEST BAYMORE RD PALO ALTO CA 943030810 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-04-17