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)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tecnis simplcty intraocular lens (iol) malfunctioned.There is no indication of patient injury and the lens has been wasted.No additional information was provided.
Additional Manufacturer Narrative
Age, weight, and ethnicity: unknown, information not provided.Date of event: unknown as information was not provided.If implanted, give date: unknown as information was not provided.If explanted, give date: unknown as information was not provided.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Historical data analysis: a search of complaints revealed one other complaint has been received for this production order number, but it is not related to this complaint.Conclusion: as a result of the investigation, there is no indication of a quality product deficiency and the reported issue could not be verified.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction info: based on further review, codes 3331 and 4109 were inadvertently omitted in the initial mdr 3012236936-2022-00280.The following sections have been updated accordingly: section h6: type of investigation: 3331 section h6: type of investigation: 4109 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: 13424704
• Report Number: 3012236936-2022-00280
• Device Sequence Number: 17079739
• Product Code: HQL
• UDI-Device Identifier: 05050474636026
• UDI-Public: (01)05050474636026(17)240122
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 02/02/2022

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: 01/22/2024
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000170
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2021
• 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: Unknown