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

Model Number	DCB00
Medical Device Problem Codes	Break (1069); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the haptic of the preloaded intraocular lens (iol) was jammed between the plunger and the injector wall while attempting to inject.The plunger damaged the haptic.So the lens was not implanted.From additional information it was learnt that the issue was noticed during handling/prior to insertion.Use error is unknown, as technician did not see the issue until after the doctor said something about it there was no abnormal condition noticed.The procedure was completed with the back up lens with the same model and diopter.There was no patent injury.There was no medical/surgical intervention required.Reportedly the scrub nurse likely did not use enough bss (balanced salt solution) while priming.No other information is available.
Additional Manufacturer Narrative
Section: a3b, a4 and a5: unknown/ asked but not available.Section :b3: date of event: unknown, not provided, section d6a: if implanted, give date: not applicable, as there is no indication that the lens was implanted section d6b: if explanted, give date: not applicable, as there is no indication that the lens was implanted section e1:surgeon's email address and phone number: unknown/ asked but not available.Section h3: other 81: 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.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: 19822639
• Report Number: 3012236936-2024-000198
• Device Sequence Number: 8694883
• Product Code: HQL
• UDI-Device Identifier: 05050474635999
• UDI-Public: (01)05050474635999(17)260209
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/24/2024

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: 02/09/2026
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000155
• 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: 07/01/2024
• Initial Report FDA Received Date: 07/24/2024
• Date Device Manufactured: 02/09/2023
• 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: 66 YR
• Patient Sex: Female