MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DFW225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	06/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a4 and a5: unknown, information was requested but not provided.Section b3: date of event: exact date is unknown/not provided.Best estimate date is prior to (b)(6 2023.Section d6a: if implanted; give date: unknown/ information was requested but not provided.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, the information has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a toric intraocular lens (iol) was explanted due to patient could not tolerate glare and halo associated with synergy lens.Another toric lens of different model (diu225), but same diopter was used as a replacement.No further information was provided.
Additional Manufacturer Narrative
Additional information: the following fileds were updated based on the additional information received from customer: section b5: additional information received indicated that the glare problems were started around 1 week after procedure on (b)(6) 2023.There was an incision enlargement during explant procedure.The patient has improved glare and vision after explant procedure and no patient injury during explant reported.Section a2: date of birth: (b)(6) 1970.Section a4: patient weight: 132 lbs.Section a5:ethnicity: hispanic/latino.Section b3: date of event: (b)(6) 2023.Section d6a.If implanted, give date: (b)(6) 2023.Section e1: initial reporter's email address: (b)(6).Corrected data: in review, it was noted that there were typos in the doctor's first and last name which were inadvertently entered in the intitial mdr report.The information has been corrected in this this supplemental mdr report and the following fields were updated accordingly: section e1: initial reporter's first/given name: (b)(6).Section e1: initial reporter's last name: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: feb 12, 2024.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection of the complaint lens reveal that it was cut in half.Further inspection reveals no issues that could cause or contribute to the complaint issues were observed.The complaint issues of "explant, halo vision, and glare" were not identified during product evaluation.Conclusion: based on the investigation, no malfunction or product deficiency was identified.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 MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 17882942
• Report Number: 3012236936-2023-02524
• Device Sequence Number: 6938720
• Product Code: MFK
• UDI-Device Identifier: 05050474752009
• UDI-Public: (01)05050474752009(17)240324
• 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,Followup
• Report Date (Section B): 03/11/2024

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: 03/24/2024
• Device Model Number: DFW225
• Device Catalogue Number: DFW225U275
• 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: 09/13/2023
• Supplement Date Received by Manufacturer: 10/11/2023; 03/10/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 11/02/2023; 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2021
• 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 Age: 53 YR
• Patient Sex: Unknown
• Patient Weight: 60 KG
• Patient Ethnicity: Hispanic