PROVISC OPHTHALMIC VISCOSURGICAL DEVICE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-01-21 for PROVISC OPHTHALMIC VISCOSURGICAL DEVICE manufactured by Alcon - Couvreur N.v./alcon - Belgium.

Event Text Entries

[175744338] No sample or confirmed lot number information has been received by manufacturing for evaluation. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[175744339] A physician reported that a viscoelastic product was used during a cataract surgery when the delivery needle was too sharp which led to a posterior capsule rupture. Unspecified medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002037047-2020-00002
MDR Report Key9612789
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-01-21
Date of Report2020-01-21
Date of Event2020-01-10
Date Mfgr Received2020-01-10
Date Added to Maude2020-01-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. JASON MICHAELIDES
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8175686438
Manufacturer G1ALCON - COUVREUR N.V./ALCON - BELGIUM
Manufacturer StreetRIJKSWEG 14
Manufacturer CityPUURS B-2870
Manufacturer CountryBE
Manufacturer Postal CodeB-2870
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NamePROVISC OPHTHALMIC VISCOSURGICAL DEVICE
Generic NameAID, SURGICAL, VISCOELASTIC
Product CodeLZP
Date Received2020-01-21
Model NumberNA
Catalog NumberASKU
Lot NumberASKU
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALCON - COUVREUR N.V./ALCON - BELGIUM
Manufacturer AddressRIJKSWEG 14 PUURS B-2870 BE B-2870


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-21

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