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

Model Number	DIU150
Medical Device Problem Codes	Crack (1135); Operating System Becomes Nonfunctional (2996); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the diu150 intraocular lens (iol) was damaged upon insertion.From the photo provided, a scratch on the iol where the iol was hung up on the plunger rod and the tip of the injector looks cracked.The doctor removed the lens and back-up iol was used successfully.There was no patient injury and no vitrectomy.No further information is available.
Additional Manufacturer Narrative
Additional information: patient weight, ethnicity and race: unknown/asked but unavailable.Date implanted: not applicable as the iol was not implanted.Date explanted: not applicable as the iol was not implanted, thus not explanted.The device was not returned for analysis.Therefore, a visual analysis of the complaint device cannot be completed.A review of the device history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.Health effect - impact code: 4631 iol removal and replacement all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information was received through follow-up and the following sections have been updated accordingly: section a2: age/date of birth: on (b)(6) 1947.It was also confirmed there was no unplanned suture(s) and the back-up/replacement lens used was the same model and diopter size.No further information is available.Section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 28-feb-2023.Section h-3: device evaluated by manufacturer: yes.Device evaluation: 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 issues could be identified.Visual inspection of the lens revealed that it was received cut into four pieces (one piece missing).The lens was cleaned and, no additional damage to the lens could be identified.Based on the return condition of the lens, no further product evaluation can be performed.The picture provided by the customer and attached into the complaint file was evaluated.It shows a single piece intraocular lens claimed to be tecnis eyhance toric ii simplicity model: diu150 being implanted.It can be observed the trailing haptic unfolded and in contact with the corneal incision, it also can be observed the delivery system with the plunger advance.In the iol a linear mark parallel to the lens toric marks can be observed from trailing haptic-optic junction to the lens periphery.The root cause of the reported event as well as its potential clinical impact cannot be determined from a picture assessment.Complaint issue " dc-cosmetic issues" was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.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: 16375654
• Report Number: 3012236936-2023-00261
• Device Sequence Number: 7544267
• Product Code: MJP
• UDI-Device Identifier: 05050474746558
• UDI-Public: (01)05050474746558(17)250814
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 03/07/2023

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: 08/14/2025
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U205
• 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: 01/19/2023
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2022
• 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 Age: 75 YR
• Patient Sex: Female