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

Catalog Number 0005450039

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cataract (1766); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

A customer reported that while using discovisc for off-label suture trabeculotomy (s-lot) bubbles notified and the crystalline lens became cloudy.Postoperative patient experienced opacity persists for one month with blurred vision.Symptoms was continued.

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

Batches are released according to the required specifications.A lot code would be required for review of the complaint history and the batch documentation.No product returned for evaluation.Inconclusive, no product returned: as no product returned and all initial testing results are within specification a conclusive root cause could not be determined.All batches are released according to the required specifications.No product returned/insufficient information: as no product is returned, the complaint could not be verified.However further trending is performed.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received indicated that procedure was suture trabeculotomy.

• Brand Name: DISCOVISC 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: 17611271
• MDR Text Key: 321827850
• Report Number: 3002037047-2023-00028
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P840064
• Number of Events Reported: 1
• 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: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0005450039
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female