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

Model Number	SN6AT3
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that following a cataract surgery with an intraocular lens (iol) implantation procedure, a scratch was observed on the implanted iol.Additional information was provided indicating that the scratches were on the central area.The patient knows that the lens is scratched, which is why she wants to change it, even with 20/20 vision.The patient's symptoms are described as "sees something on the sides".The patient is getting better but does not want a scratched lens.An iol exchange has been planned.
Additional Manufacturer Narrative
Evaluation summary: the lens was not returned for evaluation.A slit lamp photo was provided.There appears to be a linear mark/scratch across the optic center.No determination can be made from the provided photo.A qualified cartridge was indicated.It is unknown if a qualified viscoelastic was used.Based on the provided photo, the lens appears to be damaged.The root cause for this damage cannot be determined from the photograph.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11478128
• Report Number: 1119421-2021-00552
• Device Sequence Number: 14476139
• Product Code: MJP
• UDI-Device Identifier: 00380652249928
• UDI-Public: 00380652249928
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2025
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.215
• Device Lot Number: 15059037
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 03/12/2021
• 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 D; MONARCH IOL DELIVERY SYSTEM, INJECTOR; UNSPECIFIED VISCOELASTIC
• Patient Age: 71 YR
• Patient Weight: 77