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

Model Number	DXW225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Flashers (1864); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4: unknown, information was requested but not provided.Section b3: date of event: unknown, not provided, but the best estimate date is between (b)(6) 2025 and (b)(6) 2026.Section h3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Section h6: health effect - impact code: 4619 - visual disturbance-starburst-surgical intervention required; 4619 - glare surgical intervention required.Attempts has been made to obtain missing information; however, the information has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a preloaded multifocal intraocular lens (iol), model dxw225, was implanted in the patient¿s left eye.Postoperatively, the patient experienced intolerance to glare and starburst visual effects, which prevented the patient from performing certain activities that were possible prior to surgery, specifically, night driving.Additional information confirmed that the lens was subsequently explanted during a secondary surgical procedure.The original target refraction was -0.25, and the issue was determined not to be refractive in nature.The explanted lens was replaced with a zcu150 model lens.No incision enlargement, vitrectomy, sutures, or medications beyond standard postoperative care were required.At the 1-day postoperative follow-up, the patient reported no problems, and no further information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: february 10, 2026.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection revealed that the lens was coated in adhesive from the tape it was received on and viscoelastic residue.The lens was cut in half.The lens was cleaned and inspected; no further issues were identified.During the product evaluation it was confirmed that the physical characteristics of the lens matched a dxw225 model lens.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The ¿lens cut¿ observed during product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the complaint investigation results, 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: 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: 24248800
• Report Number: 3012236936-2026-000018
• Device Sequence Number: 21247089
• Product Code: HQL
• UDI-Device Identifier: 05050474763968
• UDI-Public: (01)05050474763968(17)260309
• 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: 2025
• Device Explanted Year: 2026
• 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): 03/16/2026

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: 03/09/2026
• Device Model Number: DXW225
• Device Catalogue Number: DXW225U105
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White