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

Model Number	DCB00
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, no patient contact with the product.If explanted, give date: not applicable, no patient contact with the product.The intraocular lens (iol) 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 inner box received damaged, and the seal of the intraocular lens (iol) box was broken.The issue was noticed upon opening the package and there was no patient contact with the device.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: jan 11, 2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint folding carton and complaint sterilization pouch were received.Visual inspection under magnification revealed that the complaint folding carton was received with the white seal broken.Inspection of the exterior of the folding carton further revealed damage.The sterilization pouch was inspected and, no issues could be identified with the pouch.He complaint issue sterility assurance concerns was not confirmed.The complaint issue of packaging issues was identified during product evaluation, however, because there were no photos of the shipping box it cannot be determined if there was an issue with the shipping carrier (i.E.Fedex, dhl) or distribution center.Per johnson and johnson procedure, folding cartons are individually inspected in manufacturing prior to movement to the distribution center and are individually inspected in the distribution center prior to placement in the shipping box.As a result of the investigation there is no indication of a product quality deficiency.Attempts were made contacting the customer for additional information and requested for photographs of the shipping box; however, to date no response has been received.Corrected data: in review, it was noted that "g4 -combination product" field inadvertently was left blank and not populated in the initial mdr report.In review, it was also noticed that the component code "4747" for the "packaging issues" was inadvertently not entered in the initial mdr report.The information has been captured in this supplemental mdr report and the following field was updated accordingly: section g4: combination product: no.Section h6: component codes: 4747 - packaging.All pertinent information available to johnson and 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: 16110717
• Report Number: 3012236936-2023-00056
• Device Sequence Number: 20272081
• Product Code: HQL
• UDI-Device Identifier: 05050474635920
• UDI-Public: (01)05050474635920(17)251117
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

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: 11/17/2025
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• 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