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

Model Number	ZCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3b, a4, a5 and a6: unknown, information not provided.Section d4: model number: unknown, information not provided.Section d4: catalog number: unknown, information not provided.Section d4: serial number: unknown, information not provided.Section d4: expiration date: unknown, as serial number was not provided.Section d4: unique device identifier (udi #): unknown, as serial number was not provided.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/ replaced in the initial surgery.Section e1: initial reporter: email address: unknown, information not provided.Section e1: initial reporter: telephone number: (b)(6).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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that surgeon found lens broken during the injection, resulting in that the surgery couldn't be performed.The surgeon immediately replaced with other lenses.The surgery went smoothly.No further information available.
Event or Problem Description
It was reported that surgeon found lens broken during the injection, resulting in that the surgery couldn't be performed.The surgeon immediately replaced with other lenses.The surgery went smoothly.Additional information provided the model and serial number of the lens.No further information available.
Additional Manufacturer Narrative
Additional information received provided the model and serial number of the lens.The following sections have been updated accordingly: section d4: model number: zcb00.Section d4: catalog number: zcb0000230.Section d4: serial number: (b)(6).Section d4: expiration date: dec 19, 2028.Section d4: unique device identifier (udi #): (b)(4).Section d9: device available for evaluation: no.Section d9: returned to manufacturer on: no.Section h3: device evaluated by manufacturer: no.Product evaluation was not performed because the product has not been received.The complaint issue reported could not be confirmed.Hra (health risk assessment) and human risk factor documents were reviewed for the complaint issue reported.The results of this hra and human risk factors review do not confirm that the complaint issues occurred during manufacturing; therefore, no further escalations are required.Based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.Section h4: device manufacture date: dec 19, 2024.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: 22378208
• Report Number: 3012236936-2025-000181
• Device Sequence Number: 12768772
• Product Code: HQL
• UDI-Device Identifier: 05050474531772
• UDI-Public: (01)05050474531772(17)281219
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown