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

Model Number	DIU150
Medical Device Problem Codes	Break (1069); Inaccurate Delivery (2339)
Health Effect - Clinical Codes	Eye Injury (1845); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Device evaluated by mfr: other: the device was not returned for evaluation as it was discarded; 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.Health effect - clinical code: code 4581 is to capture incision enlargement.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) trailing haptic got stuck in the cartridge, scrunching it, while being injected in the right eye.The lens was fully inserted and then removed and replaced in the same procedure.No additional surgical maneuvers were required.When the lens was removed there was minor injury to the iris, however no surgical or medical intervention was required.Another johnson and johnson iol was implanted as replacement (same model and diopter).The incision was enlarged.The lens is not available for return and evaluation.No further information was provided.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 16247601
• Report Number: 3012236936-2023-00179
• Device Sequence Number: 12413629
• Product Code: MJP
• UDI-Device Identifier: 05050474746657
• UDI-Public: (01)05050474746657(17)251021
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/26/2023

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: 10/21/2025
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U255
• 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: 01/03/2023
• Initial Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• 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 Age: 35 YR
• Patient Sex: Female
• Patient Race: White