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

Model Number	ZCB00
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information unknown/ not provided.Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Initial reporter telephone number: (b)(6).Other (81): the intraocular lens (iol) 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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after the intraocular lens (iol) was fully implanted into the patient´s eye, the surgeon noticed, that the trailing haptic was cut off.It took him a while to cut the iol into smaller pieces to remove it before implanting a new lens.The surgeon did not feel any difference when screwing the lens forward compared to other iol's, no resistance at all.The physician followed the directions for use (dfu).No details on the patient outcome since no post-operative check has taken place.The product is not available for investigation.No further information was provided.
Additional Manufacturer Narrative
Additional information: section h3 - device evaluated by manufacturer? yes device evaluation: product evaluation was performed on the customer provided photograph and video.The video displayed a lens in an eye and the haptic appeared to be at an unusual angle for delivery.The video displayed the implantation of the a lens.The lens was manipulated by a surgical implement and the haptic presented as detached.The complaint issue of haptic detached was identified during product evaluation.However, based on the complaint investigation results, the complaint issue could not be confirmed to be related to the manufacturing or design process.All pertinent information available to johnson and 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: 16925009
• Report Number: 3012236936-2023-01012
• Device Sequence Number: 17872987
• Product Code: HQL
• UDI-Device Identifier: 05050474531796
• UDI-Public: (01)05050474531796(17)250722
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2023

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 Expiration Date: 07/22/2025
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000240
• Was Device Available for Evaluation?: No
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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