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

Catalog Number 160901515SGP

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2023

Event Type  malfunction  

Event Description

A health care professional reported that during the cataract surgery, ophthalmic viscosurgical product vial was dislodged from the syringe.The surgery was completed using another product and there was no harm to the patient.

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

The initial decision to report was incorrect resulting in the initial report being submitted in error.This event defective component is not considered to be a reportable malfunction, and it is not likely that a recurrence would result in serious injury.No further reports will be scheduled under mfg report num.3002037047-2023-00048.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: 18037270
• MDR Text Key: 326916638
• Report Number: 3002037047-2023-00048
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 00000000000000
• UDI-Public: 00000000000000
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P840064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 160901515SGP
• Device Lot Number: VJ746B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1