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

Model Number	DIU600
Medical Device Problem Codes	Break (1069); Failure to Fold (1255); Operating System Becomes Nonfunctional (2996); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a4: patient weight: unknown, information was requested but not provided.Section a5: race: unknown, information was requested but not provided.Section d6a: if implanted, give date: not applicable, the lens was not implanted.Section d6b: if explanted, give date: not applicable, the lens was not implanted.Hence, not explanted.Section h3-other (81): 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.Attempts have been made to obtain missing information; however, to date, the information has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was initially reported that the customer experienced a faulty intraocular lens (iol) while performing surgery.The doctor was attempting to deliver/insert the lens until it was noticed that the lens was not folded properly and was coming out wrong due to a bent plunger rod.There was patient contact, but no injury reported.The iol was disposed of, and a replacement lens of the same model and diopter implanted in the patient¿s left eye.It was confirmed that the lens was not stuck in the cartridge.Additional information provided indicated that the haptic was damaged.The lens was partially delivered, and additional surgical maneuvers were performed, but no unplanned surgical interventions, such as vitrectomy, incision enlargement or sutures were required.The patient outcome was not provided.It was noted that the balanced salt solution (bss) that was used was room temperature and both bss and bss plus were added intraocularly.The bss introduced into the cartridge, from both the tip and from the cartridge canopy.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: 17741772
• Report Number: 3012236936-2023-02358
• Device Sequence Number: 5461358
• Product Code: MJP
• UDI-Device Identifier: 05050474750043
• UDI-Public: (01)05050474750043(17)260630
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/13/2023

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: 06/30/2026
• Device Model Number: DIU600
• Device Catalogue Number: DIU600U180
• 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: 09/13/2023
• Initial Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2023
• 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 Age: 46 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic