MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	DXR00V
Medical Device Problem Codes	Break (1069); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a4, patient weight: unknown/no information section d6a, if implanted, give date: not applicable as the iol was not implanted.Section d6b, if explanted, give date: not applicable.There's no indication the lens was implanted.Therefore, not explanted.Section h3-other (81): the device has not been 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 it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported johnson and johnson(jnj) intraocular lens (iol) got stuck at the incision.Per the technician, the iol was defective prior to implantation.Another iol of the same model and diopter were used to complete the procedure.Reportedly, the patient is doing well.No further information was provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: nov 1, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: the lens, cartridge and handpiece were received.Visual inspection under magnification revealed that a piece of the lens was torn from the body of the lens.The lens was cleaned and, no further issues were identified.The complaint cartridge was received with a piece of the lens stuck in the cartridge.Further inspection of the cartridge revealed that there was viscoelastic residue dispersed throughout the length of the cartridge, suggesting that an appropriate amount of ovd/bss was used.The complaint handpiece was received with the plunger rod advanced to the tip of the cartridge.A piece of the lens could be observed to be stuck to the plunger rod.The lens module was opened and inspected, revealing that there were not marks that would indicate that the plunger rod advanced incorrectly.The handpiece was disassembled, and the assembly was inspected, no issues that could cause or contribute to the complaint issue could be identified.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: EXTENDED DEPTH OF FOCUS 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: 17815364
• Report Number: 3012236936-2023-02442
• Device Sequence Number: 16754191
• Product Code: POE
• UDI-Device Identifier: 05050474761766
• UDI-Public: (01)05050474761766(17)250423
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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
• Report Date (Section B): 11/12/2023

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: 04/23/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU185
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 11/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2022
• 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: 63 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White