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

[21717217] On insertion of an intra occular less, a haptic broke, lens and broken haptic were removed and a second lens was implanted without difficulty. Device labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. 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, invalid data. 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: yes. 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 Number3722
MDR Report Key3722
Date Received1992-07-10
Date of Report1992-03-26
Date of Event1992-01-28
Date Facility Aware1992-01-28
Report Date1992-03-26
Date Added to Maude1993-05-03
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameALCON POSTERIOR CHAMBER LENS
Generic NamePOSTERIOR CHAMBER LENS
Product CodeHQH
Date Received1992-07-10
Model NumberMZ 60 BD
Catalog NumberNI
ID Number20.5 POWER
Device Expiration Date1995-01-01
OperatorOTHER
Device AvailabilityY
Implant FlagY
Device Sequence No1
Device Event Key3468
ManufacturerALCON SURGICAL INC


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1992-07-10

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