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

Model Number	ZCU225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Flashers (1864); Visual Disturbances (2140); Halo (2227); No Clinical Signs, Symptoms or Conditions (4582); Diplopia/Double Vision (4802)
Date of Event	08/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the non preloaded monofocal toric intraocular lens (iol) was explanted from the patient¿s right eye.The iol was explanted in a secondary surgical procedure due to complaints of positive dysphotopsia.Surgeon does not believe the lens is at fault.He believes it¿s the patient¿s pathology having ms, positive dysphotopsia and being more prone to glares as a result.He extracted and then replaced the lens of the right eye with a non-j&j iol.There was no patient injury or suture, and a vitrectomy was needed.No further information is available.
Additional Manufacturer Narrative
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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: based on the additional information received, the reason for the exchange was glare, halos, and double vision, which were received on 01/31/2024.The following codes have been added to reflect the new information: section h6: health effect: clinical code: code: 2227: halo.Section h6: health effect: clinical code: code: 4802: diplopia/double vision.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: 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: 17626514
• Report Number: 3012236936-2023-02136
• Device Sequence Number: 12648611
• Product Code: HQL
• UDI-Device Identifier: 05050474658936
• UDI-Public: (01)05050474658936(17)270716
• 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: 2023
• Device Explanted Year: 2023
• 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): 02/26/2024

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 Model Number: ZCU225
• Device Catalogue Number: ZCU225U180
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2022
• 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: 64 YR
• Patient Sex: Female