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	11/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lens was damaged.The event was noticed prior to patient contact.In the surgeon¿s opinion the product caused or contribute to the event.Reportedly, the event occurred during preloading.Likely meant during preparation.As this a preloaded device, follow-up was done to get clarification on the reported issue, but the customer did not respond with clarification.Reportedly, there was no capsule tear, no unplanned vitrectomy or sutures.No medication outside the standard of care was required.The procedure was completed using a non-preloaded jnj lens, iol model zcb00 15.5 diopter.No further information was provided.
Additional Manufacturer Narrative
If implanted, give date: not applicable as the iol was inserted and removed within the same procedure.If explanted, give date: not applicable as the iol was inserted and removed within the same procedure.Device evaluation: product testing could not be performed as the product was not returned.The reported event could not be verified, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that two other complaints were received for this production order.Complaints are not related.Conclusion: based on the investigation, no product deficiency was identified.Attempts have been made to obtain the missing information.However, to date it has not been received.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: feb 21, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: partial return.No iol was received as part of this return.Visual inspection under magnification of the handpiece revealed that it was received with the plunger rod fully advanced.The cartridge tip had excessive stress marks.The handpiece was disassembled, and the assembly was inspected, no issues that could cause or contribute to the complaint issue could be identified.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: 15978531
• Report Number: 3012236936-2022-03011
• Device Sequence Number: 5858487
• Product Code: HQL
• UDI-Device Identifier: 05050474635999
• UDI-Public: (01)05050474635999(17)240812
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/21/2023

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: 08/12/2024
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2021
• 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