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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Date of Event	11/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the multifocal intraocular lens(iol) had significant glare and halo came from a light source.The patient had to close and/or squint their left eye to see better.It was first reported to the surgeon on (b)(6) 2021, during a post-op visit, and he kept coming back with the same complaint.Symptoms significantly interfere with the patient¿s daily activities.Lens was replaced with another company iol.Pre-op uncorrected and best corrected visual acuity was -0.75 +0.25 x180 20/40 uc 20/40 bc, and post-op best corrected visual acuity was -1.75+0.50 x060 20/40.Post-procedure, the patient is doing well.There was no injury, and surgical and medical interventions were required.No further information is available.
Additional Manufacturer Narrative
Unknown/asked but not provided.Caucasian.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.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.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: may 16, 2024.Section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection was performed on the suspect product and found the lens to be cut in half.The lens was cleaned and inspected and presented with no issues that would have contributed to the complaint event.No further evaluation was performed.The complaint issue "halo vision", "glare", "blurry vision" and "explant" were not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: the complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 19347542
• Report Number: 3012236936-2024-000125
• Device Sequence Number: 2568904
• Product Code: MFK
• UDI-Device Identifier: 05050474750463
• UDI-Public: (01)05050474750463(17)240803
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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): 06/21/2024

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: 08/03/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• 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: 67 YR
• Patient Sex: Male