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	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that a patient underwent cataract surgery with implantation of a single-piece, non-preloaded toric intraocular lens (iol) in the left eye.At the 1-week postoperative follow-up visit, the patient reported increased blurred vision and expressed interest in undergoing an iol exchange procedure.No patient or user harm was reported.Additional information received with product return confirmed that an explant procedure was performed.The originally implanted lens was subsequently explanted during a secondary surgery and replaced with a non-johnson & johnson iol (model rxlal6005, 21.0 d).The reported reason for the iol exchange was a postoperative refractive outcome more myopic than the intended plano target.Preoperative refraction was documented as +0.25 +0.75 x 180 with a best spectacle-corrected visual acuity (bscva) of 20/40.Postoperative refraction prior to the exchange was -1.25 +0.50 x 092 with a bscva of 20/30+2, indicating a myopic outcome relative to the planned target.The patient did not experience a loss of two or more lines of bscva and reported no limitations in activities of daily living.There were no intraoperative or postoperative surgical complications, no unplanned interventions aside from the elective iol exchange, and no patient injury reported.The patient's ocular history included status post lasik in both eyes with enhancement procedures, which may have impacted iol power calculation accuracy.Following the iol exchange, the patient achieved a plano outcome and was reported to be doing well.Based on the available information, the device was considered to have caused or contributed to the event.No further information was provided.

• 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: 25436638
• Report Number: 3012236936-2026-000151
• Device Sequence Number: 21416308
• Product Code: HQL
• UDI-Device Identifier: 05050474657854
• UDI-Public: (01)05050474657854(17)280605
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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: ZCU150U230
• 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: 05/13/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• 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 Weight: 133 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White