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

Model Number	DXW300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Flashers (1864); Blurred Vision (2137); Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
The dxw300 model intraocular lens (iol) was reported to have been implanted in the patient¿s ocular dexter (right eye).Patient is unhappy with the lenses that were implanted.Patient described experiencing visual fluttering in his vision since implantation, similar to a strobe light.It is especially hard when he reads.Poor night vision.At night, the patient does not see much light.He provided examples of difficulty walking his dog at night and trouble getting out of bed in the night without being able to see.Patient experiences difficulties with driving and sees halos.He had cataract surgery, to eliminate an astigmatism.He wore glasses and over the years, his prescription remained unchanged.He's now having trouble obtaining glasses to assist his visual issues.Patient shows no symptoms of glaucoma, macular degeneration, or dry eye.Eye pressure is good: 11 and 13.Additional information was received indicating the iol was explanted in a secondary surgical procedure and replaced with a non-johnson & johnson iol, clareon cca020 lens.There was no patient injury, no medical intervention, and no surgical intervention during the lens exchange procedure.The suspect iol is not available for return as it was discarded.No further information is available.
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: unknown as information was not provided.Section a-4 patient weight: unknown as information was not provided.Section a-5 patient ethnicity: unknown as information was not provided.Section a-6 patient race: unknown as information was not provided.Section b-3: date of event: unknown as information was not provided.The best estimation date is between (b)(6) 2024 (iol implant and explant dates).Section h-3 device evaluated by manufacturer: the device was not returned for evaluation as it was discarded.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 report will be filed.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: 21146376
• Report Number: 3012236936-2025-000013
• Device Sequence Number: 18542357
• Product Code: HQL
• UDI-Device Identifier: 05050474765245
• UDI-Public: (01)05050474765245(17)250811
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2025

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: 08/11/2025
• Device Model Number: DXW300
• Device Catalogue Number: DXW300U155
• 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: 01/08/2025
• Initial Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2022
• 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: 59 YR
• Patient Sex: Male