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

Model Number	DIB00
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Eye Injury (1845); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an unknown model intraocular lens (iol) was explanted from the patient's operative eye due to doctor complaints of wrong diopter size.The following are all unknowns: replacement lens information, medical or surgical intervention, and patient status.No further information is available.
Additional Manufacturer Narrative
Additional information: sections a-2 patient age/date of birth, a-4 patient weight, and a-5 patient ethnicity and race: unknown/asked information unavailable.Section b-3: date of event: unknown/asked information unavailable.Section d-4 model number: unknown, as device serial number was not provided.Section d-4 catalog number: unknown as device serial number was not provided.Section d-4 device serial number: unknown as information was not provided.Section d-4 device expiration date: unknown as device serial number was not provided.Section d-4 udi number: the unique device identifier (udi) number is unknown as device serial number was not provided.Section d-6a date implanted: unknown/asked information unavailable.Section h3-81: device serial number is not available; therefore, no further investigation can be performed.The device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.If there is any further relevant information received, a supplemental medwatch report will be filed.Section h-4 device manufacture date: unknown as device serial number was not provided.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.
Additional Manufacturer Narrative
Corrected data: further information was provided reporting the patient complained of vision and stronger power was needed.The replacement iol was a dib00 20.0 diopter iol.There was no vitrectomy, no delay in procedure, and daily activities were not significantly affected.Patient outcome post-lens exchange was reported as fully recovered.No further information is available.The following fields were updated based on the information received through follow-up: section b-3: date of event: the best estimation date is between (b)(6) 2023 (iol implant and explant dates).Section d-1 brand name: tecnis simplicity.Section d-2 common device name: intraocular lens.Section d-4 model number: dib00.Section d-4 catalog number: dib00u0180.Section d-4 device serial number: (b)(6).Section d-4 device expiration date: 12-mar-2026.Section d-4 udi number: (b)(4).Section d-6a date implanted: (b)(6) 2023.Section d-6b date explanted: (b)(6) 2023.Section h-4 device manufacture date: mar 12, 2023.Section h-6 health effect - clinical code: 2137.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: 18289061
• Report Number: 3012236936-2023-03067
• Device Sequence Number: 20385178
• Product Code: HQL
• UDI-Device Identifier: 05050474731714
• UDI-Public: (01)05050474731714(17)260312
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2026
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0180
• 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: 11/17/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown