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

Model Number	ZCU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a single piece non-preloaded monofocal intraocular lens (iol) was fully implanted in a patient's right eye.Post op the patient experienced unexpected refractive outcome that included over-correction, loss of two or more lines of best spectacle corrected visual acuity (bscva), and difficulties with depth perception, which impacted daily activities such as driving and walking and required iol explant.The account reported patient¿s pre-existing conditions may have affected the calculation (refer to b7).The explant procedure was successful and the iol was replaced with a back up iol with the similar model with 12.5 diopter.Pre-operative refraction was recorded as -4.50 +2.00 x109, with best spectacle corrected visual acuity of 20/50, while post-operative refraction was noted as -1.50 +0.75 x110, achieving corrected visual acuity of 20/20.The initial target of refraction was plano (-0.25).The patient was noted as "recovering" and achieving uncorrected visual acuity of 20/20 one week after the operation.No sutures, incision enlargement or vitrectomy required.No medications outside of standard of care were prescribed.The device did not cause or contribute to the event.No further information was provided.
Additional Manufacturer Narrative
Section a4: weight: unknown/not provided.Section a5: ethnicity: unknown/not provided.Section a6: race: unknown/not provided.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.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
The following field was updated accordingly: upon further review it was noticed that there was a need to add codes.Section h6: impact code: added 4619 and clinical code: added 2140: visual disturbance to capture the difficulties with depth perception, which impacted daily activities such as driving and walking.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: 24258783
• Report Number: 3012236936-2026-000016
• Device Sequence Number: 15470245
• Product Code: HQL
• UDI-Device Identifier: 05050474657663
• UDI-Public: (01)05050474657663(17)300730
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: 2025
• 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): 04/15/2026

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 Model Number: ZCU150
• Device Catalogue Number: ZCU150U135
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2025
• 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: 70 YR
• Patient Sex: Male