MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL; INTRAOCULAR LENS

Model Number	DAT015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Inflammation (1932); Iritis (1940); Visual Impairment (2138); Visual Disturbances (2140); Eye Pain (4467); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A surgeon has reported that following a cataract extraction with intraocular lens (iol) implant procedure, the patient complains of poor distance vision.Additional information was provided by the surgeon that approximately one month following her cataract extraction with iol implantation procedure, the patient experienced slight inflammation and light sensitivity.Her postoperative steroid drop was increased.The surgeon felt that the vision was reduced due to dryness.The patient was given artificial tears and an anti-inflammatory topical medication.The patient returned 6 weeks following the procedure, complaining of double vision, pain, and poor vision.This is gradually worsening.The symptoms seem to be worse in the sunshine.These problems have been fairly stable since the onset and have been persistent.She also reports pain in her face and around her eyes/cheek areas which become worse by the end of the day.The vision is still very blurry far away, but okay at near/intermediate.She is unable to read street signs and feels unsafe to drive at the moment.The patient has a history of postoperative iritis which is improving.Posterior capsule opacification was noted on examination.

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12479743
• Report Number: 1119421-2021-01756
• Device Sequence Number: 17127668
• Product Code: POE
• UDI-Device Identifier: 00380652424677
• UDI-Public: 00380652424677
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2025
• Device Model Number: DAT015
• Device Lot Number: 15098202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/16/2021
• 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; SINSKEY HOOK; UNSPECIFIED AUTOMATED I/A HANDPIECE; UNSPECIFIED VISCOELASTIC
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR