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

Model Number	SN60WF
Medical Device Problem Codes	Entrapment of Device (1212); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	08/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that the intraocular lens got trapped in the incision during implantation of the intraocular lens (iol).The surgeon advanced the lens and noticed a fracture in the optics.The incision was widened.The iol was removed and discarded.A back up lens was implanted without harm to the patient.Additional information has been requested; however, further information has not been received.
Additional Manufacturer Narrative
The product was returned for analysis and damage was observed to the iol (intraocular lens).No cartridge was returned.Iol returned pressed down into well area of iol case base.Solution is dried on both surfaces of the optic and haptics.One haptic is nicked/chipped-rejectable near the gusset area, the other is bent/twisted.The optic is cracked/fractured almost dividing the iol in two and scratched/marked-rejectable.Unable to conduct dimensional testing due to condition of returned sample.The root cause for the reported complaint "trapped in the incision, fracture of the optics, incision widened, in and out" could not be determined.Only the iol was returned for evaluation.No cartridge was returned.Due to this, we are unable to complete a thorough investigation to determine a root cause.The reported complaint is lacking in relevant information such as associated products used to complete a thorough investigation.Due to the lack of information, we are unable to verify if the iol contributed to the event.Unable to conduct dimensional testing due to condition of returned sample.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12364715
• Report Number: 9612169-2021-00172
• Device Sequence Number: 3974190
• Product Code: HQL
• UDI-Device Identifier: 00380655093290
• UDI-Public: 00380655093290
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2026
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.250
• Device Lot Number: 25130407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown