ALCON POSTERIOR CHAMBER LENS MZ 60 BD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-10 for ALCON POSTERIOR CHAMBER LENS MZ 60 BD manufactured by Alcon Surgical Inc.

Event Text Entries

[959] During insertion of intra occular lens, into the right eye, a haptic broke off the lens. There was no tissue damage noted by the physicians. Device labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device not serviced in accordance with service schedule. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: component failure, telemetry failure, unanticipated short term complication of procedure. Conclusion: device failure occurred and was related to event, device was out of spec in a manner that relates to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service, device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3734
• MDR Report Key: 3734
• Date Received: 1992-07-10
• Date of Report: 1992-03-26
• Date of Event: 1992-01-21
• Date Facility Aware: 1992-01-21
• Report Date: 1992-03-26
• Date Reported to Mfgr: 1992-01-23
• Date Added to Maude: 1993-05-03
• 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
• Health Professional: 0
• Initial Report to FDA: 0
• 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: ALCON POSTERIOR CHAMBER LENS
• Generic Name: POSTERIOR CHAMBER LENS
• Product Code: HQH
• Date Received: 1992-07-10
• Model Number: MZ 60 BD
• Catalog Number: NI
• Lot Number: NI
• ID Number: 21.5 POWER
• Device Expiration Date: 1995-01-01
• Operator: OTHER
• Device Availability: Y
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 3480
• Manufacturer: ALCON SURGICAL INC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-10