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

Model Number	DIB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2,a3, a4 and a5: unknown/ not provided.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.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.
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) had a damaged leading haptic.During the procedure, there was patient contact with the iol, which was subsequently replaced with an iol of the same model and diopter.Additional information indicates that the leading haptic was damaged upon insertion, but the lens was not implanted.There was no injury or further intervention required.No additional information is available.
Additional Manufacturer Narrative
Section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: march 2025.Section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification was performed on the suspect product and found the lens was stuck in the cartridge with a portion of the lens sticking out of the cartridge tip.The lens was observed to be damaged with a detached and missing haptic.Viscoelastic residue was observed to be distributed throughout the cartridge, no damage to the cartridge was observed.The lens module was opened and inspected and ovd was observed inside, indicating that an excessive amount of ovd may have been used which may have contributed to the complaint issue reported.The handpiece and plunger rod were inspected, and no issues were observed.No further issues were identified and no further evaluation was performed.The complaint issue was not identified during product evaluation.The observed is similar to the reported complaint issue.However, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be 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: 21209638
• Report Number: 3012236936-2025-000013
• Device Sequence Number: 19819095
• Product Code: HQL
• UDI-Device Identifier: 05050474731646
• UDI-Public: (01)05050474731646(17)270709
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/22/2025

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: DIB00U0145
• 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: 12/30/2024
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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: Unknown