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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - COUVREUR N.V./ALCON - BELGIUM PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC
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ALCON - COUVREUR N.V./ALCON - BELGIUM PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC Back to Search Results
Catalog Number 960569MA3001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Endophthalmitis (1835)
Event Date 02/05/2022
Event Type  Injury  
Manufacturer Narrative
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.The manufacturer internal reference number is:(b)(4).
 
Event Description
A physician reported that a patient experienced endophthalmitis in the operated eye that was noted during the post-operative check-up.Additional information has been requested but not yet received.
 
Manufacturer Narrative
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.The manufacturer internal reference number is:(b)(4).
 
Event Description
A physician reported that a patient experienced endophthalmitis in the operated eye that was noted during the post-operative check-up.Additional information has been requested but not yet received.
 
Manufacturer Narrative
Complaint trending reviewed for the lot code provided.No similar complaint found.There was no sample returned for evaluation.The chemical lab has tested the ph and osmo of a reference sample and the results are within specifications for the tested parameters.The complaint condition could not be confirmed.Batch records were reviewed, and all testing results met specifications for this lot code at the time of release.Additionally, there were no deviations noted during batch record review.As no manufacturing related issues were identified and no sample is available, a conclusive root cause could not be determined.All batches are released according to the required specifications.Based on the complaint information and the investigation results, we can conclude that the disposition of the product remains unchanged.As no product is returned and/or insufficient product data is available, the complaint could not be verified.The manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.
 
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Brand Name
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
Type of Device
AID, SURGICAL, VISCOELASTIC
Manufacturer (Section D)
ALCON - COUVREUR N.V./ALCON - BELGIUM
rijksweg 14
puurs B-287 0
BE  B-2870
Manufacturer (Section G)
ALCON - COUVREUR N.V./ALCON - BELGIUM
rijksweg 14
puurs B-287 0
BE   B-2870
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key13632235
MDR Text Key286326390
Report Number3002037047-2022-00026
Device Sequence Number1
Product Code LZP
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
P890047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number960569MA3001
Device Lot Number21G26MA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ACRYSOF SINGLEPIECE IOL.; BSS STERILE IRRIGATING SOLUTION.; CENTURION SURGICAL PROCEDURE PAK.; CENTURION VISION SYSTEM.; UNSPECIFIED BALANCED SALT SOLUTION.
Patient Outcome(s) Other;
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