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

Model Number	SN60WF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.(b)(4).
Event or Problem Description
A physician reported that during a cataract surgery with an intraocular lens (iol) implantation, one of the haptics broke when the lens was injected.The fractured posterior haptic was observed at the time of implantation.It broke and had to be removed.Patient impact was reported as corneal edema requiring a subtenon steroid treatment.Additional information has been requested.
Additional Manufacturer Narrative
Evaluation summary: the lens was returned positioned incorrectly in the lens case.The photos provided match the observations of the returned sample.Solution and blood was observed on the lens.One haptic was broken in the gusset area.The broken portion was not returned.The lens was pressed against a post in the lens case.The optic was torn\split from the edge across the center of the lens.Qualified associated products were indicated.The reported broken haptic damage was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met release criteria.Based on our observation, it can be reasonably concluded that the damage was not manufacturing related.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: 11595402
• Report Number: 1119421-2021-00693
• Device Sequence Number: 11664187
• Product Code: HQL
• UDI-Device Identifier: 00380655095782
• UDI-Public: 00380655095782
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.290
• Device Lot Number: 12636126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention