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

Model Number	DIU225
Medical Device Problem Codes	Break (1069); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the preloaded toric intraocular lens (iol) haptic started to shear while being inserted.The lens was partially inserted.It is unknown if any resistance was felt when advancing the lens.The procedure was completed successfully using a back-up lens (same model and diopter).It is unknown if the issue was related to use error.There was no patient injury.No medical or surgical intervention was required.There are no planned interventions.The patient outcome was satisfactory.No further information was provided.
Additional Manufacturer Narrative
Section a2, a4, and a5: unknown; requested but not provided.Section d6a: if implanted, give date: not applicable, as the lens was not fully implanted.Section d6b: if explanted, give date: not applicable, as the lens was not fully implanted.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 and complaint history for production order for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
The product was received for evaluation.Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: mar 19, 2024.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection of the complaint simplicity reveal that the cartridge tip was slightly deformed, and the plunger rod tip was damaged.Ophthalmic viscosurgical device (ovd) was observed to be disbursed throughout the cartridge.The lens module was inspected, and no issues were identified.The handpiece was disassembled and no issues that could cause or contribute to the complaint issues were observed.No lens or haptic was received for evaluation.The complaint issue "delivery issue" and "haptic damaged" were not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: based on the complaint investigation results, the product was released within specifications.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: 18838179
• Report Number: 3012236936-2024-00587
• Device Sequence Number: 7499496
• Product Code: MJP
• UDI-Device Identifier: 05050474747173
• UDI-Public: (01)05050474747173(17)260702
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 04/10/2024

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: 07/02/2026
• Device Model Number: DIU225
• Device Catalogue Number: DIU225U220
• 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: 02/14/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2023
• 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 Sex: Unknown