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

Model Number	DIB00
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6, patient information: declined due to patient privacy and health insurance portability and accountability act (hipaa) regulation.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 was not returned for evaluation as it was discarded.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.An attempt was made to obtain the missing information.However, it was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded johnson and johnson (jnj) intraocular lens (iol) was inserted into the patient¿s eye.One of the haptics was broken off.The iol was removed and replaced with the same model and diopter.The new lens was inserted and the procedure was completed successfully with no issues.The customer pondered if the lens was missing the haptic or was the haptic torn off when injecting it into the eye.They could not find the haptic in the injector or anywhere else.There was no injury to the patient.No complications such as a capsule tear, vitrectomy, incision enlargement or sutures.No further information was provided.

• 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: 21611313
• Report Number: 3012236936-2025-000075
• Device Sequence Number: 12653558
• Product Code: HQL
• UDI-Device Identifier: 05050474731806
• UDI-Public: (01)05050474731806(17)270114
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

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: DIB00U0220
• 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: 03/11/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2024
• 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