MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number SN6AT4

Device Problems Defective Device (2588); Scratched Material (3020)

Patient Problems Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2021

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.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported that during an intraocular lens (iol) implantation procedure, the iol was damaged.There was difficulty with insertion and the lens was not placed.Additional information has been requested however, further information has not been received.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received indicating difficulties with placing the lens in the cartridge correctly, the lens was found to be scratched following insertion in the eye.The incision size was increased and the lens was removed.The iris herniated and a partial iridectomy was performed.The iol was replaced and the procedure was completed.The following day the patient's intraocular pressure was high.Further information has not been received.

Manufacturer Narrative

Product evaluation: the product was returned for analysis and the reported complaint was observed.There have been no other complaints for this lot.Additional observations were as follows: iol returned cut in half in iol case.Solution is dried on both surfaces of the optic and haptics.One haptic is broken/torn and is returned.The optic is torn/split-cut dividing the iol in two(2) and scratched/marked-rejectable.Additional information: the complainant states the use of non company cartridge which is not qualified to be used with the associated iol model/viscoelastic combination.Root cause: while we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow dfu, as the customer states the use of non-qualified combination.The use of nonqualified combination may result in delivery issues and/or damage.The product was subject to handling and the reported damage was highlighted post implantation.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• MDR Report Key: 11541520
• MDR Text Key: 241428100
• Report Number: 9612169-2021-00067
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 00380652250474
• UDI-Public: 00380652250474
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.225
• Device Lot Number: 21188479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMO CARTRIDGE; PROVISC OVD
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR