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

Model Number	DIU150
Medical Device Problem Codes	Material Fragmentation (1261); Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight, ethnicity: unknown/ not provided.Implant date: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Explant date: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.The device was not received; 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 an intraocular lens (iol) had an issue where the back haptic was ripped off from the iol during the pre-loaded lens deployment process.It was noted that the damaged lens was explanted from the right eye and successfully replaced with a back-up iol of the same make and power.No other information was provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes.Returned to manufacturer on: jan.8, 2022.Section h3: device evaluated manufacturer? yes.Device evaluation: visual inspection under magnification revealed trace amounts of viscoelastic residue inside of the cartridge.Further observation revealed that the cartridge tip was damaged and that there was a portion of a detached haptic in the lens module.The handpiece was disassembled and the assembly was inspected, presenting with no further issues.The complaint issue delivery issue could not be confirmed.Only the detached haptic portion of the iol was received, therefore, the lens cannot be further evaluated.The complaint issue detached haptic could be confirmed; however, this may be attributed to an inadequate amount of ovd, suggested by the trace amounts of viscoelastic residue inside of the cartridge, and cannot be confirmed to be related to a manufacturing issue.Therefore, no product deficiency could be determined.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no additional complaints were received from this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12842408
• Report Number: 2020664-2021-08090
• Device Sequence Number: 4317437
• Product Code: MJP
• UDI-Device Identifier: 05050474746428
• UDI-Public: (01)05050474746428(17)240302
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2022

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: 03/02/2024
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U140
• 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: 10/29/2021
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2021
• 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: Male