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

Lot Number ASKU

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/20/2023

Event Type  malfunction  

Event Description

A nurse reported that during intraocular lens (iol) implantation procedure, a streaks/threads were noted on the iol.The lens was remain implanted as the surgeon said that it acts like a membrane.Additional information has been requested and received stating that the streaks/ threads could not be polished away during the surgery as they stick to the iol.There was no patient harm.There are three medical device reports associated with this event.This is 3 of 3.

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.A sample has been received by manufacturing that has not yet been evaluated.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Corrected information provided in section h.10.Upon receiving additional information it was clarified that the suspect product involved in this event is not manufactured by our company.No further reports will be scheduled under mfg report num.3002037047-2023-00024.The manufacturer internal reference number is: (b)(4).

• Brand Name: CELLUGEL 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: 17057367
• MDR Text Key: 316484401
• Report Number: 3002037047-2023-00024
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2023
• 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
• Treatment: ACRYSOF SINGLEPIECE IOL.; ACRYSOF SP FOLDABLE 6.0 OPTIC FX.; ALCON CELLUGEL.; HPMC 2%.; MONARCH III D CARTRIDGES.; MONARCH III IOL DELIVERY SYST.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.
• Patient Age: 78 YR
• Patient Sex: Female