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

Model Number	DXR00V
Medical Device Problem Codes	Crack (1135); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6, patient information: unknown/not provided.Section d6a, if implanted, give date: not applicable as the iol was removed and replaced during the same procedure.Section d6b, if explanted, give date: not applicable as the iol was removed and replaced during the same procedure.Therefore, not explanted.Section h3, device evaluated by manufacturer: 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 that the cartridge of the preloaded johnson and johnson (jnj) intraocular lens (iol) did not work as intended cracked at the tip.There was a lot of resistance, and the tip cracked.The iol did not contact the eye only the cartridge tip.The device was removed and replaced with a backup lens of the same model and diopter.The procedure was completed without complications.No further information was provided.
Additional Manufacturer Narrative
Additional information.Section d9: device available for evaluation? yes section d9: date returned to manufacturer: apr 21, 2025 section h3: evaluated by manufacturer: yes device evaluation: the complaint handpiece was received.Visual inspection under magnification revealed the complaint handpiece was received with the plunger rod advanced.Viscoelastic residue was observed to be evenly distributed throughout the cartridge.The cartridge tip was observed to be torn and damaged.The damage extended to the cartridge tube.The lens module was inspected revealing no issues.The device assembly was inspected revealing no issues.The plunger rod and plunger rod advancement was inspected revealing no issues.No iol was received for evaluation.Based on the complaint investigation results, the product was released within specifications.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: 21242444
• Report Number: 3012236936-2025-000022
• Device Sequence Number: 8495807
• Product Code: POE
• UDI-Device Identifier: 05050474761629
• UDI-Public: (01)05050474761629(17)251108
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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: 11/08/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU115
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALANCED SALT SOLUTION (BSS).
• Patient Sex: Unknown