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	Eye Injury (1845)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: male.Section b-3: date of event: unknown/asked information was not provided.The best estimation date is between on (b)(6) 2024 (iol implant and explant dates).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 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.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 & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The zcb00 model intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye).For unknown reasons, the iol was explanted in a secondary surgical procedure and replaced with a zcb00 19.0 diopter iol.There is no indication of medical intervention or surgical intervention during the explant procedure.Patient prognosis post lens exchange is unknown.No further information is available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes section d9: returned to manufacturer on: may 1, 2025 section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification was performed on the suspect product and found the lens was cut and coated in viscoelastic residue.The lens was cleaned and inspected and damage on the surface of the lens was identified.No further issues were observed.No further evaluation was performed.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.Conclusion: based on the investigation, no malfunction or product deficiency was identified.Corrected data: in review, it was noticed that in section "h11" of the initial mdr report, it was inadvertently indicated that "a3b" information is not available, which is incorrect.It was also noted that field "d10" was inadvertently left blank in the initial mdr report; therefore, the information has been corrected in this supplemental mdr report as indicated below: section a3b: gender: cis gender man/boy section d10: concomitant medical products: duovisc/provisc.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: 21506133
• Report Number: 3012236936-2025-000062
• Device Sequence Number: 19945724
• Product Code: HQL
• UDI-Device Identifier: 05050474531741
• UDI-Public: (01)05050474531741(17)270813
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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 Model Number: ZCB00
• Device Catalogue Number: ZCB0000215
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC/PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male