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

Model Number	DCB00
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date implanted: not applicable as the iol was not implanted.Date explanted: not applicable as the iol was not implanted.Device evaluation: product evaluation could not be performed since, at the time of this investigation, the product had not been received.If the product is returned regarding this evaluation the case will be reopened to complete sample evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.No nc/er was found as part of the manufacturing record review.Historical data analysis: a search revealed that no other complaints have been received for this production order (po) number.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the pre-loaded intraocular lens (iol) haptic was kinked while loading, during handling and prior to insertion.Reportedly there was no patient contact.Additional information was received and it was confirmed that the procedure was completed successfully using back-up dcb00 17.0 iol in the same procedure.Patient outcome post-procedure was reported as no reportable issues.No further information is available.
Additional Manufacturer Narrative
Additional info: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 28-dec-2022.Device evaluation: the complaint lens and handpiece were received loose inside of the original folding carton.Visual inspection under magnification revealed that the complaint lens was received coated in viscoelastic residue.The lens was cleaned and no issues could be identified.Visual inspection of the handpiece revealed that it was received with the plunger rod fully advanced.No issues with the handpiece could be identified.Complaint issue ¿haptic damaged¿ was not confirmed.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.Corrected data: additional information was provided with the product return and indicated the event date as 11/9/2022.Therefore, section b3 date of event has been updated in this supplemental mdr.Additionally, upon further review, it was noted that the reported loading issue was inadvertently not included in the initial mdr, therefore, it is captured in this supplemental mdr.The following sections have been updated accordingly: section b3: date of event: 11/9/2022 section h6: medical device problem code: 2524 loading issue 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: 15966028
• Report Number: 3012236936-2022-02996
• Device Sequence Number: 17371732
• Product Code: HQL
• UDI-Device Identifier: 05050474636026
• UDI-Public: (01)05050474636026(17)250724
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/08/2023

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: 07/24/2025
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000170
• 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: 11/17/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2022
• 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: Unknown