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

Model Number	DIU225
Medical Device Problem Codes	Break (1069); Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) was defective and the inserter was not working properly.There was no patient contact.No further information was provided.
Additional Manufacturer Narrative
Sex, weight and ethnicity: unknown, information not provided.Implanted date: if implanted, give date: not applicable, as there is no indication that the lens was implanted explanted date: if explanted, give date: not applicable, as there is no indication that the lens was implanted 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 the missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: the initial report 3012236936-2022-01343 should have included the following information and the current report captures this correction: section h6: component codes: 4734 - ejector.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information was received from the patient id card and an implant notification card, received along with the product for evaluation and following fields were updated accordingly: section a2: age/date of birth: (b)(6)1948.Section b5: the eye affected of the patient was right eye.Section e1: reporter name and title: dr.Gaurav singh section e3: occupation: physician section d9: device available for evaluation? yes section d9: returned to manufacturer: yes section d9: returned to manufacturer on: may 31, 2022 section h3: device evaluated by manufacturer: yes device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed that the complaint handpiece was received with the lens stuck inside of the cartridge tip and with the plunger rod overriding the lens.Inspection of the cartridge revealed that the cartridge tip was bent, in a way consistent with a handpiece that was dropped.Inspection of the external assembly revealed no issues that could contribute to a stuck lens.The handpiece was disassembled and the assembly was inspected, no assembly issues were identified.Inspection of the plunger rod revealed no issues.The complaint lens was removed from the cartridge and cleaned however, it came out of the cartridge in pieces.The lens was revealed to be torn, have scratches on the optic body, and to have a detached haptic.The reported complaint issues were not confirmed.Therefore, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 14479792
• Report Number: 3012236936-2022-01343
• Device Sequence Number: 17327385
• Product Code: MJP
• UDI-Device Identifier: 05050474747081
• UDI-Public: (01)05050474747081(17)240703
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2022

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: 07/03/2024
• Device Model Number: DIU225
• Device Catalogue Number: DIU225U175
• 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: 05/23/2022
• Supplement Date Received by Manufacturer: 05/23/2022; 08/01/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 05/24/2022; 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2021
• 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