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 Codes	Corneal Edema (1791); Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narratives/data: section a4 and a5: incomplete /unknown/ asked but not available.Section h3: other 81: the device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.The following sections have been updated accordingly: section h6: health effect - clinical code:2140 - visual disturbances: used to indicate photophobia/increased light sensitivity-persistent and visual disturbance- dysphotopsia requiring surgical intervention.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported patient presented with blurred vision, tired eyes, dysphotopsia, sensitivity to sunlight, and feeling she was seeing the edges of the lenses and distorted vision in (b)(6) 2023 and reported it has been going on like this since the cataract surgery in 2022.There are no known quality issues with the lens.Patient had seen multiple doctors and have asked for the lens to be removed.The intraocular lens (iol) was explanted from the right eye due to the patient complaints and an adjustable lens was implanted in its place.Patient is doing better now, although his vision is still somewhat blurred and there is significant corneal edema after the iol exchange that is resolving.For the corneal edema, no intervention was required beyond the usual eye drops, and it lasted more than 15 days after the lens explant.The product is not available for return.No other information was provided.

• 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
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18937976
• Report Number: 3012236936-2024-00573
• Device Sequence Number: 6971616
• Product Code: POE
• UDI-Device Identifier: 05050474579170
• UDI-Public: (01)05050474579170(17)231016
• 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 Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2024

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: 10/16/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0240
• 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: Not provided
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2018
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 97 KG
• Patient Race: White