ALCON POSTERIOR CHAMBER INTRAOCULAR LENS MZ20BD

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 INTRAOCULAR LENS MZ20BD manufactured by Alcon Surgical Inc.

Event Text Entries

[16786809] After implanting iol in patients left eye, surgeon noticed hapti{ to be fractured. Surgeon removed iol after it had been inserted without any problem. A new iol was then inserted. No apparent injury to the patient was noted by the surgeon. 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. Results of evaluation: telemetry failure, none or unknown. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3732
MDR Report Key3732
Date Received1992-07-10
Date of Report1992-04-30
Date of Event1992-04-28
Date Facility Aware1992-04-28
Report Date1992-04-30
Date Reported to Mfgr1992-04-29
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 INTRAOCULAR LENS
Generic NamePOSTERIOR CHAMBER LENS
Product CodeHQH
Date Received1992-07-10
Model NumberMZ20BD
Catalog NumberMZ20BD
Lot Number243643
ID Number25.0 POWER
OperatorOTHER
Device AvailabilityN
Implant FlagY
Device Sequence No1
Device Event Key3478
ManufacturerALCON SURGICAL INC


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1992-07-10

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