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); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/04/2023

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 63 years male patient experienced corneal edema and pupillary dilation in the right eye for which 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

Additional information provided in sections h.6 and h.10.Batch records were reviewed, and all testing results met specifications for this lot code at the time of release as the initial test results are within specifications and no sample is available, a conclusive root cause could not be determined.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).None - no product returned/insufficient information: as no product is returned and/or insufficient product data is available.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: 18855606
• MDR Text Key: 337098430
• Report Number: 3002037047-2024-00004
• 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: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• 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
• Date Manufacturer Received: 03/26/2024
• 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: 63 YR
• Patient Sex: Male