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 Problem Cataract (1766)

Event Type  Injury  

Event Description

A customer reported that while using discovisc for off-label suture trabeculotomy (s-lot) bubbles noted and the crystalline lens became cloudy.Next day cataract was observed.Symptoms 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

As no lot code was provided and no sample was returned for evaluation ; a conclusive root cause could not be determined for the reported bubbles complaint.A sample or lot code would be required for review of the complaint history and manufacturing record associated with the reported product.Insufficient information provided for investigation or root cause of this complaint, no action is required at this time.As no lot code or sample was received, no further risk assessment can be performed.The manufacturer internal reference number is: (b)(4).

• 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: 17611168
• MDR Text Key: 321824904
• Report Number: 3002037047-2023-00027
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

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: 11/02/2023
• 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: 61 YR
• Patient Sex: Female