MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	DIU225
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported upon insertion, the haptic of the diu225 intraocular lens (iol) was sheared off and left in the inserter; there was patient contact.There was no incision enlargement, no serious patient injury, no suture(s), no use error, and no vitrectomy.The diu225 remains implanted in the patient's ocular dexter (right eye) and is not available for return.No further information is available.
Additional Manufacturer Narrative
Additional information: patient weight and patient ethnicity and race: unknown/asked information unavailable.Date explanted: not applicable as the iol remains implanted, therefore not explanted.The device was not returned for evaluation as it remains implanted in the patient's ocular dexter (right eye).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.
Additional Manufacturer Narrative
Device evaluation: no iol was received as part of this return.Visual inspection under magnification revealed that the complaint handpiece was received with the plunger rod fully advanced.The handpiece was disassembled, and the assembly was inspected.No issues that could cause or contribute to the complaint issue were identified.Additionally, the detached haptic described in the initial complaint could not be identified.The cp provided photo was evaluated.The photo shows the suspect handpiece sn sticker with no issues.Based on the photo, further evaluation could not be performed.Complaint issue haptic detached could not be confirmed during product or photo evaluation, and no issues were identified.Conclusion: based on the complaint investigation results, the product was released within specifications and a relationship between the device and the reported incident could not be determined.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 IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 16718171
• Report Number: 3012236936-2023-00897
• Device Sequence Number: 15246751
• Product Code: MJP
• UDI-Device Identifier: 05050474747135
• UDI-Public: (01)05050474747135(17)240715
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/07/2023

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: 07/15/2024
• Device Model Number: DIU225
• Device Catalogue Number: DIU225U200
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• 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