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

Model Number SN60WF

Device Problems Entrapment of Device (1212); Material Split, Cut or Torn (4008)

Patient Problem Eye Injury (1845)

Event Date 08/04/2021

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 268034696
• Report Number: 9612169-2021-00172
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380655093290
• UDI-Public: 00380655093290
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: P930014
• 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: 08/12/2022

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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 08/25/2021
• Supplement Dates Manufacturer Received: 07/18/2022
• Supplement Dates FDA Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention