MAUDE Adverse Event Report: ALCON - COUVREUR N.V./ALCON - BELGIUM PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; OPHTHALMIC EXCIMER LASER SYSTEM

Catalog Number 960569CDN001

Device Problem Particulates (1451)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/15/2023

Event Type  malfunction  

Event Description

A nurse reported that during cataract surgery after the application of viscoelastic an foreign body was identified in the eye and it was visible only under ophthalmic operating microscope.There was no patient harm.Additional information has been requested.

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).

Manufacturer Narrative

No similar complaints have been received so far for this lot.All batches are released according to the required specifications.No sample was available for evaluation.According to local procedures, retain sample testing was not performed.Since no manufacturing related deviations were identified and no sample has been returned, a conclusive root cause could not be determined.A potential root cause for foreign material could be attributed to: - a component related issue.This is unlikely as during incoming inspection and during in process control no deviations were reported concerning this complaint.- an incident during filling.This is unlikely as no in process control deviations related to this complaint were reported during filling.A root cause outside the control of the manufacturing site could not be eliminated.The complaint sample is required for further investigation.Review of the lot complaint history and manufacturing documentation found no issues that would have contributed to the reported complaint.The manufacturer internal reference number is: (b)(4).

• Brand Name: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Type of Device: OPHTHALMIC EXCIMER LASER SYSTEM
• 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 Key: 16689394
• MDR Text Key: 312870855
• Report Number: 3002037047-2023-00011
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P890047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 960569CDN001
• Device Lot Number: VD296A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1