MAUDE Adverse Event Report: ALCON - COUVREUR N.V./ALCON - BELGIUM PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC

Catalog Number 0005690064

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Edema (1791); Intraocular Pressure Decreased (4468)

Event Date 05/09/2023

Event Type  Injury  

Event Description

A customer reported that an ophthalmic viscoelastic used for the cataract surgery, which was found to low in viscosity and the patient experienced corneal edema in left eye and maintaining anterior chamber for which medical intervention was provided.The current condition of the patient was recovering.

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

All batches are released according to the required specifications; all testing results were within specification for this batch.No sample available for evaluation.Since no sample was returned and all initial test results are within specifications, a conclusive root cause could not be determined for the adverse events.A potential root cause could be attributed to a quality issue, but this is unlikely since chemistry data met the requirements prior to release of product.Potential root cause for the viscosity (physical properties) complaint condition include: improper storage which can result in an altered viscosity.Viscosity degrades when stored at temperatures above 2-8c and the higher the temperature the more rapid rate of viscosity loss (non-linear).As no product is returned and/or insufficient product data is available, the complaint could not be verified.The manufacturer internal reference number is:(b)(4).

• 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 Key: 18856513
• MDR Text Key: 337113465
• Report Number: 3002037047-2024-00006
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P890047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0005690064
• Device Lot Number: VF582A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 70 YR
• Patient Sex: Female