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

Model Number	DIB00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a4- unknown, not provided.Section d6a-not applicable, the lens was not implanted.Section d6b- not applicable, the lens was not implanted, hence, not explanted.Section h3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending will be performed.Upon completion of this review, if there is any further relevant information, a supplemental medwatch will be filed.An attempt has 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 reported that a preloaded monofocal intraocular lens (dib00) experienced an issue in which the cartridge tipped open during lens insertion.The cartridge came into contact with the patient's eye, however, no medical intervention was required.The procedure was successfully completed using the same model and diopter intraocular lens.The patient is reported to be doing well.No additional information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review it was noticed the affected eye (left eye) was inadvertently not included in the initial medwatch report.The following section have been updated accordingly.Section b5: the affected eye was the patient's left eye.Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: sep 29, 2025.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection reveal that the lens was stuck in the tip of the cartridge with a portion of lens sticking out of the cartridge tip.The cartridge was damaged with a stress mark that led to a crack on the cartridge tip.Ophthalmic viscoelastic device (ovd) was observed inside the cartridge.The lens module, handpiece, and plunger rod were inspected, and no issues were identified.The lens was observed to be torn and damaged, however, it could not be removed from the cartridge for further evaluation.The complaint issue of "cartridge tip cracked/damaged" was identified during product evaluation.However, based on the investigation results, the issue could not be confirmed to be related to manufacturing or design process.Conclusion: based on the investigation, no malfunction or product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: 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: 23009828
• Report Number: 3012236936-2025-000234
• Device Sequence Number: 15901640
• Product Code: HQL
• UDI-Device Identifier: 05050474731844
• UDI-Public: (01)05050474731844(17)270925
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/15/2025

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 Model Number: DIB00
• Device Catalogue Number: DIB00U0240
• 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: 09/03/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White