MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned for analysis.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.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported via a sample return that the "lens had frosting on it" noted when inserting in eye.Additional information was provided indicating that when the lens was implanted, the surgeon felt it was not clear, had a haze, opted to remove the iol and implant another iol.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: the lens was returned for evaluation.Solution and blood are dried on the lens.The lens appears to have been cut in half, typical of insertion and removal from the eye.One half of the lens with a haptic was returned for evaluation.The lens was cleaned with lphse.Light edge damage is observed.The reported haze is not observed on the lens.Associated products were not provided.It is unknown if qualified products were used.The reported event of haze was not observed.The lens was returned cut in half, typical of insertion and removal from the eye.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling the manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12033505
• Report Number: 1119421-2021-01245
• Device Sequence Number: 3299032
• Product Code: HQL
• UDI-Device Identifier: 00380655093146
• UDI-Public: 00380655093146
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2025
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.175
• Device Lot Number: 15098828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR