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

Lot Number ASKU

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Intraocular Pressure Increased (1937); Uveitis (2122); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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.Literature article: luther l.Fry, m.D." postoperative intraocular pressure rises: a comparison of healon, amvisc, and viscoat" (cataract refract surg jul/1989:15 415-420).The manufacturer internal reference number is: (b)(4).

Event Description

A clinical study reported that an ophthalmic visco surgical device was used in a study where the product was aspirated, the patients experienced high intra ocular pressure given with medication, cells and flares, pain, corneal striations post operatively.The product was sticky and was difficult to be removed from anterior chamber.

Manufacturer Narrative

Additional information was provided in sections.All batches are released according to the required specifications.A lot code would be required for review of the complaint history and the batch documentation.Adverse events are followed-up by manufacturer.No product returned for evaluation.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.As no product is returned, the complaint could not be verified and therefore no action is initiated.However further trending is performed.The manufacturer internal reference number is: (b)(4).

• Brand Name: VISCOAT 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: 15864514
• MDR Text Key: 304286149
• Report Number: 3002037047-2022-00083
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2023
• 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