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

Model Number	DIB00
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	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: unknown/asked information was not provided.Section a-4 patient weight: unknown/asked information was not provided.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.A search of complaints revealed that one (01) additional complaint folder was found as part of this production order (po) number ¿ lead haptic not folded.Complaint issues reported are not related.Based on chr results, no further actions are required.Shipping history review confirmed the product was delivered to the customer after the expiration date.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The pre-loaded dib00 model intraocular lens (iol) was expired (14-apr-2024) when it was implanted in the patient's eye on (b)(6) 2024.Patient outcome was reported as good, patient can see well, and no issues.The suspect iol is not available for return as it remains implanted.No further information is available.

• 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: 20233601
• Report Number: 3012236936-2024-000252
• Device Sequence Number: 18183496
• Product Code: HQL
• UDI-Device Identifier: 05050474731455
• UDI-Public: (01)05050474731455(17)240414
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2024

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: 04/14/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0050
• 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: 08/20/2024
• Initial Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2021
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White