MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	ZXT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Flashers (1864); Visual Disturbances (2140); Halo (2227)
Date of Event	08/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight, ethnicity: unknown/no information.Other serious (important medical events): patient finds symptoms debilitating.If explanted; give date: not applicable as the device remains implanted.The device is not returning for evaluation as it remains implanted.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Received report indicating the patient visited their doctor at 6-month post-op.Their visual acuity was reported as follows, uncorrected distance visual acuity (ucdva) for the right eye (od) was 20/30 and for the left eye (os) 20/25.Their best corrected distance visual acuity (bcdva) was 20/20 for both eyes (ou).The patient reported being very bothered by halos, very bothered by starbursts, moderately bothered with sensitivity to light, very bothered by glare while working on a computer and reading books.There are no plans for surgical intervention and the patient is not on any medication outside of the regular curriculum.However, the symptoms are reported to be debilitating to the patient.No further information was provided.This is report 2 of 2 for the left eye.Another report is being submitted for the right eye.
Additional Manufacturer Narrative
Additional information.It was reported the subject came in for their 1-year study visit on (b)(6) 2022; visual acuity ucdva od 20/30 ou; bcdva 20/20 ou.The following complaint was reported on patient reported visual symptoms questionnaire (prvsq): slightly bothered by halos-driving, moderately bothered by starbursts-driving, extremely bothered by poor low light vision- reading, computer work, close up work.No plans for surgical intervention.No further information was provided.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12502862
• Report Number: 2020664-2021-07187
• Device Sequence Number: 16966304
• Product Code: POE
• UDI-Device Identifier: 05050474605626
• UDI-Public: (01)05050474605626(17)230626
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

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: 06/26/2023
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Female