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

Model Number	DIU150
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the surgeon was injecting an intraocular lens (iol) it somehow twisted when coming out of the injector and did not sit correctly once completely in the eye.The surgeon did not like the way the lens was, so he removed it and placed another johnson & johnson lens (same model and diopter) as a replacement.No other medical interventions were done.Patient is doing good post-operatively.No further information is available.
Additional Manufacturer Narrative
Implant date: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Explant date: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.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.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional info: further information was provided and reported patients date of birth, gender, weight, and eye affected was the left eye.No other information was provided.The following sections have been updated accordingly: section a2: age/date of birth: (b)(6) 1947.Section a3: sex/gender: male.Section a4: patient weight: 185 pounds.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in reviewing the initial mdr, it was noticed that section h6 component code 4755 was inadvertently not included; therefore, it is captured in this supplemental report.The following section has been updated accordingly: section h6: component code: 4755 lens damage and positioning issue.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: 15611869
• Report Number: 3012236936-2022-02620
• Device Sequence Number: 16831660
• Product Code: MJP
• UDI-Device Identifier: 05050474746572
• UDI-Public: (01)05050474746572(17)250327
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2022

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: 03/27/2025
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U215
• 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: 09/26/2022
• Supplement Date Received by Manufacturer: 10/17/2022; 11/11/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 11/09/2022; 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2022
• 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 Sex: Male
• Patient Weight: 84 KG