NLCON POSTERIOR CHAMBER LENS MZ60BD NONE

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 NLCON POSTERIOR CHAMBER LENS MZ60BD NONE manufactured by Alcon Surgical Inc.

Event Text Entries

[2082] When placing an alcon iol in the right posterior chamber of the eye, one of the haptic broke off. This required the removal of the implant. It was removed without problem and a new implant was inserted in the posterior of the right eye. Broken implant was returned to the vendor. Device labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. 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. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3721
MDR Report Key3721
Date Received1992-07-10
Date of Report1992-03-02
Date of Event1992-01-07
Date Facility Aware1992-01-07
Report Date1992-03-02
Date Reported to Mfgr1992-01-08
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 NameNLCON POSTERIOR CHAMBER LENS
Generic NamePOSTERIOR CHAMBER LENS
Product CodeHQH
Date Received1992-07-10
Model NumberMZ60BD
Catalog NumberNONE
Lot NumberNONE
ID Number25.5,12.5MM LENS
Device Expiration Date1996-01-01
OperatorOTHER
Device AvailabilityY
Device Age01-JAN-92
Implant FlagY
Device Sequence No1
Device Event Key3467
ManufacturerALCON SURGICAL INC


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1992-07-10

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