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

Model Number	DCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight, ethnicity: unknown; requested but not provided.If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.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, 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 the intraocular lens (iol) was fully inserted in the left eye and then removed and replaced with another johnson and johnson iol (same model and diopter) in the same procedure due to a crack in the lens/defective lens.There was no medical or surgical intervention required and no patient injury.The patient is fine.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jan 20, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: the complaint device was received for evaluation.Visual inspection under magnification revealed lens damage (crack) on the optic zone and no additional lens defects before and after cleaning the lens.A damaged plunger rod tip (bent) was observed on the handpiece and no additional defects or assembly issues were observed before and after disassembling the handpiece.The complaint issue of "lens damaged" 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 issue during the product evaluation could not be confirmed to be related to a manufacturing or design issue as there were no observed scratches in the lens module indicating that the defect was not present prior to advancing the lens.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.Corrected data: in review, it was noted that "g4 -combination product" field inadvertently was left blank and not populated in the initial mdr report.The information has been entered in this supplemental mdr report and the following field was updated accordingly: section g4: combination product: no all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 16163514
• Report Number: 3012236936-2023-00101
• Device Sequence Number: 6958580
• Product Code: HQL
• UDI-Device Identifier: 05050474635999
• UDI-Public: (01)05050474635999(17)250201
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/17/2023

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: 02/01/2025
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000155
• 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: 12/20/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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 Sex: Male