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

Model Number SN60WF

Device Problems Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2022

Event Type  Injury  

Event Description

A physician reported that there was a foreign material in the lens.The patient impact is unknown.Additional information was requested.

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.Seven (7) photos provided showing an implanted lens.There is a dark line on the optic that could be interpreted as the reported complaint "foreign material".Reported complaint cannot be confirmed from the provided photo.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was requested and received from quality investigator that the lens was returned.

Manufacturer Narrative

The product was returned for analysis and the reported complaint was observed.Iol(intraocular lens) returned in two pieces (cut in half) in the lens case.Solution is dried on both surfaces of the optic and one haptic.One haptic is broken/torn and not returned, the other haptic is bent/deformed.The optic is torn/split-cut dividing the iol in two and scratched/marked-rejectable.There is what appears to be a solid line of material adhered to the optic surface.Iol cleaned, line of material still present after cleaning.Seven photos provided showing an implanted iol.There is a dark line on the optic that could be interpreted as the reported complaint "foreign material".Reported complaint cannot be confirmed from the provided photo.The root cause is deemed to be manufacturing related.During lab analysis, foreign material present on the iol was found the best match to be iol lens material.The product did not meet specifications.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Corrected information was provided in h.6.Fda code 2944 a nd 114 was submitted incorrectly during initial report.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: 13964479
• MDR Text Key: 288318377
• Report Number: 9612169-2022-00142
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380655093252
• UDI-Public: 00380655093252
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.230
• Device Lot Number: 25281985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention