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

Model Number	SN60AT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during a cataract extraction with intraocular lens implant procedure, while leaving the cartridge at the time of implantation, there was a break of the iol.Additional information was provided that the iol broke during implantation, at the phase of the iol exiting from the cartridge nose.The break occurred inside the eye.A similar lens was implanted a few minutes later through the same cartridge, with the same injector, with the same viscoelastic.The patient's condition is satisfactory.The postoperative period was with no abnormalities.
Additional Manufacturer Narrative
Product evaluation: the product was returned for analysis and the reported complaint was observed.Photo review: the returned photo shows iol on a white background.There is a line/mark observed on the iol optic.A definitive determination of damage cannot be made without the evaluation of the physical product.Additional observations were as follows: iol returned wrapped in gauze in a clear zip lock bag.Solution is dried on both surfaces of the optic and haptics.Both haptics are intact.The optic is torn/split-cut, has loose fibers & particulate and has scratches/marks-rejectable.Additional information: the complainant indicates the use of a non company product as a viscoelastic, which is not qualified for use with associated iol model.The root cause may be related to a failure to follow the directions for use (dfu) as the surgeon states the use of a non-qualified viscoelastic.Due to differing material properties, the use of a non-qualified viscoelastic may result in delivery issues and/or damage.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF 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
• MDR Report Key: 11841069
• Report Number: 9612169-2021-00121
• Device Sequence Number: 4634686
• Product Code: HQL
• UDI-Device Identifier: 00380650130204
• UDI-Public: 00380650130204
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

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: 06/30/2024
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.150
• Device Lot Number: 21250789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 09/17/2021
• 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: BVI HPMC HYPROMELLOSE OPHTH SOLN USP 2% W\V; MONARCH IOL DELIVERY SYSTEM, CARTRIDGE C; MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED; BVI HPMC HYPROMELLOSE OPHTH SOLN USP 2% W\V; MONARCH IOL DELIVERY SYSTEM, CARTRIDGE C; MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED
• Patient Age: 89 YR