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

Model Number	DAT015
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Scratched Material (3020)
Health Effect - Clinical Codes	Corneal Edema (1791); Dry Eye(s) (1814); Foreign Body Sensation in Eye (1869); Headache (1880); Visual Disturbances (2140); Irritability (2421); Eye Pain (4467)
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
An ophthalmic technician reported after the intraocular lens (iol) implantation the patient had experienced foreign body sensation felt like having a glass inside the eye.The patient also had irritation, photophobia, shadow, peripheral and throbbing pain in the eye.Vision was blurred and the patient was sensitive to light.The first follow up visit post surgery revealed that the patient had microcystic edema.Ten days later the patient came back for a routine post operative examination and the corneal health was much better than the previous week.A week later the patient cornea was clear.Additional information has been requested, however no new information is available.
Additional Manufacturer Narrative
Additional information provided.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and received stating there was a scratch or smudge on the lens and the patient had experienced eye pain and foreign body sensation which had effected the vision.The lens was explanted for a replacement lens in a secondary procedure.
Additional Manufacturer Narrative
Only a portion of the lens with an attached haptic was returned in the replacement lens case.Solution was dried on the lens.The returned optic portion has a deep scrape mark on the anterior side of the optic.The cut optic damage observed is typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.The other portion of the cut lens was not returned for evaluation.Associated products were not provided.It is unknown if qualified products were used.Based on the attached source document the clinical reason for explant is "scratch or smudge on the lens that is affecting the vision".The reported scratch/mark was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded that the damage is 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.Power and resolution testing could not be conducted due to the extensive optic damage.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.Information was provided that the 17.0 diopter, (1.5 extended depth of focus) lens model was exchanged for a 16.5 diopter, add power +2.2 & 3.2 lens model.The manufacturer internal reference number is: (b)(4).

• 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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12859719
• Report Number: 1119421-2021-02197
• Device Sequence Number: 4546744
• Product Code: POE
• UDI-Device Identifier: 00380652424578
• UDI-Public: 00380652424578
• 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
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2022

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: 06/05/2026
• Device Model Number: DAT015
• Device Lot Number: 15211996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 12/17/2021; 02/02/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 01/07/2022; 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOTEMAX EYE DROPS.; PREDNISOLONE ACETATE 1% EYEDROPS - TID.; PROLENSA EYE DROPS.; TOBRADEX EYE DROPS.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 47 YR
• Patient Sex: Female