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

Model Number	DXR00V
Medical Device Problem Codes	Application Program Problem: Dose Calculation Error (1189); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Eye Injury (1845); Visual Impairment (2138)
Date of Event	01/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4 and a5: unknown/ asked but not available.Section d6a: if implanted, give date: unknown/ asked but not available.Section h3: other 81: 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 will be filed.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the multifocal intraocular lens (iol) was explanted due to the wrong power.The suspect iol was replaced with another johnson and johnson same model higher diopter iol.Patient status post-procedure is also unknown.No further information is available.
Additional Manufacturer Narrative
Corrected data: upon further review found that initial mdrs were submitted with the incorrect udi number.Corrected mdr as below section d4: udi number: the correct udi is (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: based on the additional information received, the codes from the initial mdr of 1845 - eye injury, 1535 - incorrect, inadequate or imprecise result or readings are no longer applicable.The following codes have been added to reflect the new information: section h6: health effect - clinical code: code2138 - visual impairment section h6: medical device problem code: 1189 - application program problem: dose calculation error.Based on the additional information received that the event was like a calculation error hence the change in diopter size.Patient is a lot better and happy now, 20/20.There was an unexpected post-op refraction post-implant, hence explant was performed.Doctor did not think that there was a product quality issue with the original lens.No other information was provided, therefore, this event is assessed as not reportable.There will no longer be any further reporting under mfr report number 3012236936-2024-00423.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: EXTENDED DEPTH OF FOCUS 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: 18785362
• Report Number: 3012236936-2024-00423
• Device Sequence Number: 12702299
• Product Code: POE
• UDI-Device Identifier: 05050474761735
• UDI-Public: (01)05050474761735(17)250418
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 04/22/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU170
• 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: 02/02/2024
• Supplement Date Received by Manufacturer: 03/08/2024; 04/04/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 03/28/2024; 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• 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 Age: 53 YR
• Patient Sex: Female