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 Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer account provided photo/images of the dcb00 model intraocular lens (iol).Photo/images appear to show a tear or break of some sort at the edge of the iol, which may be consistent with the complaint reported (surgeon identified a rupture at the end of the iol).No further information is available.
Additional Manufacturer Narrative
Additional information: section a-2 patient age/date of birth: unknown/asked information unavailable.Section a-3a patient sex: unknown/asked information unavailable.Section a-3b patient gender: unknown/asked information unavailable.Section a-4 patient weight: unknown/asked information unavailable.Section a-5 patient ethnicity: unknown/asked information unavailable.Section a-6 patient race: unknown/asked information unavailable.Section b-3: date of event: unknown/asked information unavailable.Section d-6a date implanted: not applicable as there is no indication the iol was implanted.Section d-6b date explanted: not applicable as there is no indication the iol was implanted, therefore not explanted.Section e-1 reporter telephone number: (b)(6) - field only accepts the us phone number format.Section h-3 device evaluated by manufacturer: the device 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 report will be filed.Section h-6 health effect - clinical code: 4581 incision enlargement.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.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: 19543497
• Report Number: 3012236936-2024-000168
• Device Sequence Number: 7704443
• Product Code: HQL
• UDI-Device Identifier: 05050474635968
• UDI-Public: (01)05050474635968(17)260522
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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: 05/22/2026
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000140
• 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: 05/24/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2023
• 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