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

Model Number	ZCB00
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section b3: date of event: exact date is unknown/not provided.Best estimate date is on or prior to apr 19, 2024.Section d6a: if implanted, give date: not applicable, there is no indication that the lens was implanted.Section d6b: if explanted, give date: not applicable, there is no indication that the lens was implanted.Hence, not explanted.Section e1: initial reporter last name: information unknown/not provided.Section h3: the 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 will be filed.Attempts have been made to obtain additional information regarding the event; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The customer provided photos of an intraocular lens (iol) with showing lens with part of the stem severed (lens and haptic were damaged).No further information was provided.
Additional Manufacturer Narrative
Additional information: no suspect product was received; however, a customer photo was provided and evaluated.The photo displays the suspect lens, and it can be observed to be torn.A portion of one haptic can also be observed to be detached.Due to no product being received, no further evaluation could be performed and no further issues could be identified.The complaint issue "lens damaged" was not identified during photo evaluation.The observed "iol torn" is similar to the reported complaint issue.However, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.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
Corrected data: in review, it was noticed that the date (apr 19, 2024) was inadvertently entered in the section "g3 - date received by manufacturer" of the initial mdr report, which is incorrect.The correct date received by manufacturer that should have been entered is "apr 18, 2024".Also, it was noted that the device code "1261 - material fragmentation" was inadvertently not entered in the initial mdr report; therefore, the information has been corrected in this supplemental mdr report.The following fields were updated accordingly: section g3: date received by manufacturer: apr 18, 2024.Section h6: device code(s): 1261 - material fragmentation.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Additional Manufacturer Narrative
Additional information/corrected data: the following information was corrected/updated accordingly when product.Investigation was updated: conclusion: the complaint issue "haptic detached" was identified during photo evaluation.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: 19307517
• Report Number: 3012236936-2024-000139
• Device Sequence Number: 6380919
• Product Code: HQL
• UDI-Device Identifier: 05050474531826
• UDI-Public: (01)05050474531826(17)270805
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup,Followup
• Report Date (Section B): 06/17/2024

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: ZCB0000255
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 05/20/2024; 06/10/2024; 06/17/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/08/2024; 06/10/2024; 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2023
• 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
• Patient Sex: Unknown