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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The zcb00 model intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye).Post-operatively, the patient was having difficulty with depth perception and overall vision, specifically while driving.Thus the iol was explanted in a secondary surgical procedure.Replacement lens information was not provided.Patient prognosis post lens exchange is also unknown.No further information is available.
Additional Manufacturer Narrative
Additional information: section h-3 device evaluated by manufacturer: the complaint 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 report will be filed.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson and 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: december 17, 2025.Section h-3: device evaluated by manufacturer: yes.Device evaluation: product received in a patient sample cup without original packaging; serial number cannot be confirmed.During a visual inspection, the device was inspected under magnification.The lens was received cut in half and coated in viscoelastic residue.The lens halves were cleaned revealing a scratch on one lens half.The physical characteristics of the received lens was confirmed to match that of a zcb00 model lens.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.The manufacturing records for the product were reviewed; the units were released in accordance with specifications.The lens diopter results obtained from the miq electronic system show that this production order was released within diopter specifications.A search of complaints revealed that one (01) additional complaint folder was found as part of this production order (po), loading issues.The complaint issues reported are not related.Based on complaint history review (chr) results, no further actions are required.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction was 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: 23888862
• Report Number: 3012236936-2025-000344
• Device Sequence Number: 11938645
• Product Code: HQL
• UDI-Device Identifier: 05050474531789
• UDI-Public: (01)05050474531789(17)281219
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: ZCB00
• Device Catalogue Number: ZCB0000235
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic