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)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a-4 patient weight: unknown/asked information unavailable.Section h6: health effect - clinical code: 2140 glare, 2140 visual disturbance- dysphotopsia.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search of complaints revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.Attempts have been made to obtain missing information; however, the account did not have the information.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 implanted into the patient¿s ocular dexter (right eye).In a secondary surgical procedure, the iol was explanted due to complaints of glare 90% of the time, colors dull, film over vision, and "never good" vision.Another johnson & johnson lens, model zcu150 19.0 diopter was implanted as a replacement.There no serious injury, no suture(s), and no vitrectomy.It is unknown if the incision was enlarged.Patient's post-lens exchange outcome was reported as patient happy with vision.No further information is available.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 13-jul-2023.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received inside of the original lens case.Visual inspection under magnification revealed that the complaint lens was received coated in viscoelastic residue.The lens was cleaned and, no issues that could cause or contribute to the complaint issue could be identified.Complaint issues could not be confirmed during product evaluation, and no issues were identified.Conclusion: based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: upon further review, it was noted that section b-4 date of this report reported in follow-up #1 mdr was missing when the report was submitted.Therefore, the information is captured in this supplemental report.Section b-4 date of this report: 04-aug-2023.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: 17084127
• Report Number: 3012236936-2023-01307
• Device Sequence Number: 6070013
• Product Code: MFK
• UDI-Device Identifier: 05050474751231
• UDI-Public: (01)05050474751231(17)240406
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 08/04/2023

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: 04/06/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U185
• 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: 05/13/2023
• Supplement Date Received by Manufacturer: 08/04/2023; 08/04/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 08/04/2023; 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: White