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

Model Number	DCB00
Medical Device Problem Codes	Use of Device Problem (1670); Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the pre-loaded dcb00 model intraocular lens (iol) that was implanted in the patient's operative eye was expired.Date of surgery was (b)(6) 2023 and product expiration date was 07-apr-2023.There were no visual issues reported by the patient.No further information is available.
Additional Manufacturer Narrative
Section d-6b date explanted: not applicable as the iol remains implanted; therefore, not explanted.Device evaluation: product evaluation was not performed because the product has not been received.If product is received after initial closure, the pi and cp (if necessary) may be re-opened to complete the return investigation.The complaint issue reported could not be confirmed.Device history record (dhr) review: the manufacturing records for the product were reviewed, the units were released in accordance with specifications.No nc/er was found as part of this manufacturing records review.A search of complaints revealed that one (01) additional complaint folder was found as part of this production order (po) number ¿ expired product used.Although these complaint issues reported are related, the issue could not be confirmed as related to manufacturing.Based on chr results, no further actions are required.Conclusion: based on the complaint investigation results, the product was released within specifications and the complaint issue reported could not be confirmed.No product deficiency or product malfunction was 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: 20061037
• Report Number: 3012236936-2024-000236
• Device Sequence Number: 7820976
• Product Code: HQL
• UDI-Device Identifier: 05050474636361
• UDI-Public: (01)05050474636361(17)230407
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2024

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: 04/07/2023
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000340
• Was Device Available for Evaluation?: No
• 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: 08/07/2024
• Initial Report FDA Received Date: 08/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2020
• 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: Female