MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DFW150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age or date of birth, weight, & ethnicity: information unknown/not provided.Date of event: exact date unknown/not provided.Best estimate date is between 6/6/2022-10/31/2022.Email address: unknown/not provided.Device evaluated by mfr: 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.An attempt has been made to obtain missing information; however, no definitive 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 an intraocular lens (iol) was explanted from the patients operative eye due to lack of near vision and blurred vision.No other information was provided.
Additional Manufacturer Narrative
Additional info: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: dec 19, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received inside a specimen cup.No other product or components were received.Visual inspection under magnification revealed that the lens was received cut in half and coated in viscoelastic material.The lens was cleaned and inspected under magnification and lens damage was observed on the edge of the lens, and haptic damage was also identified.The complaint issue ¿blurry vision¿ was not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: in reviewing the supplemental mdr, it was noted that the following information was inadvertently not included; therefore, it is captured in this supplemental report.Further information was provided with the product return and reported patient's date of birth, visual acuity (va) pre-operative(op) was 20/25 and va post-op distance 20/25, near 20/40.The patient is sensitive to light, activities affected driving at night and reading computer in the right eye.The patient tolerated the procedure well and left the operating room in stable condition and without complications.No other information was provided.The following sections have been updated accordingly: section a2: age/date of birth: on (b)(6) 1949.Section h6: health effect - clinical code: 2140 photophobia, 2140 visual disturbance- dysphotopsia.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 15874746
• Report Number: 3012236936-2022-02912
• Device Sequence Number: 2468403
• Product Code: MFK
• UDI-Device Identifier: 05050474751200
• UDI-Public: (01)05050474751200(17)241006
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 02/14/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/31/2022
• Supplement Date Received by Manufacturer: 01/13/2023; 02/14/2023
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 02/06/2023; 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female