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

Model Number	ZKB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: male section a-5 patient ethnicity: unknown/asked information was not provided.Section a-6 patient race: unknown/asked information was not provided.Section d-6a date implanted: not applicable as the iol was removed and replaced during the initial procedure.Section d-6b date explanted: not applicable as the iol was removed and replaced during the initial procedure; therefore, not explanted.Section h-3 device evaluated by manufacturer: the complaint device was not returned for evaluation as it was discarded.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.Section h-6 health effect - impact code: 4625 - incision enlargement and vitrectomy.Section h-6 health effect - clinical code: 4581 - incision enlargement.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
During insertion, the zkb00 model intraocular lens (iol) perforated/punctured the posterior capsule.It was confirmed the iol was fully inserted in the patient's eye.The incision was enlarged and an anterior vitrectomy was performed however, there was no serious patient injury and no sutures.The procedure was completed using a ar40e 20.5 diopter iol that was implanted in the patient¿s ocular dexter (right eye).Patient prognosis post-procedure was reported as excellent.The suspect iol is not available for return as it was discarded.No further information is available.
Additional Manufacturer Narrative
Additional information was received, indicating a nurse from the customer account submitted a voluntary report to the fda - report # mw5171460.Therefore, the updated information is captured in this supplemental report.The following field has been updated accordingly: section e-4 initial reporter also sent the report to fda? updated to yes.Device evaluation: product evaluation was not performed because the product has not been received.If product is received after initial closure, the pi and cp (if necessary) may be re-opened to complete the return investigation.The manufacturing records for the product were reviewed, the units were released in accordance with specifications.The search revealed that no other complaints were received for this production order (po) number.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.All pertinent information available to johnson & 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: 28-jul-2025.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received on the lens daisy wheel.The original folding carton, an open sterilization pouch, implant notification card, implant identification card, and patient stickers were also received.During a visual inspection, the device was inspected under magnification.The lens was received cut in half (one lens half was not received) and stuck to the lens daisy wheel.The received half was unstuck and cleaned revealing lens edge damage.No further evaluation was performed.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The other issues observed during the product evaluation could not be confirmed to be related to the manufacturing or design process.The manufacturing records for the product were reviewed, the units were released in accordance with specifications.A search revealed that no other complaints have been received for this production order (po) number.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: LENS, MULTIFOCAL INTRAOCULAR
• 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: 22287845
• Report Number: 3012236936-2025-000172
• Device Sequence Number: 12994327
• Product Code: MFK
• UDI-Device Identifier: 05050474560123
• UDI-Public: (01)05050474560123(17)280618
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 09/09/2025

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: ZKB00
• Device Catalogue Number: ZKB00U0220
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 09/02/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/22/2025; 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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 Sex: Male
• Patient Weight: 82 KG