MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age or dob, weight, ethnicity: unknown, not provided.Date of event is unknown.The best estimate time would be between (b)(6) 2021 and (b)(6) 2021, as the surgeon indicated 5 weeks post-op examination when he explanted the lens.If implanted; give date: the exact date of implant is unknown/not provided.The best estimate is (b)(6) 2021 as the surgeon indicated 5 weeks post-op examination when he explanted the lens.The intraocular lens (iol) is not returning for evaluation as it was discarded by the customer; therefore, failure analysis of the complaint device cannot be completed.A review of the device 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
It was reported that the patient received bilateral implants with the symphony intraocular lenses (iols).The right eye was done 5 weeks ago and the left eye 3 weeks ago.Reportedly the patient has as she wanted.She was j3 at 18 inches but she wants closer.The surgeon explanted the lens from the patient's right (od) eye and replaced it with a synergy iol, dfr 18.5 diopter.The procedure went fine and the patient will be seen by him for a follow up visit.The doctor is waiting until then to good distance and intermediate.The patient complains that she does not have as much near vision make any initial determination of how the new lens is working out.The explanted lens was discarded.No further information was provided.This report represents the right (od) eye.The lens in the left eye remains implanted.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12517107
• Report Number: 2020664-2021-07491
• Device Sequence Number: 17433181
• Product Code: POE
• UDI-Device Identifier: 05050474579064
• UDI-Public: (01)05050474579064(17)240129
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

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: 01/29/2024
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0185
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention