MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS 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	Flashers (1864); Visual Disturbances (2140); Halo (2227)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a synergy intraocular lens (iol) was explanted from the patient's right (od) eye.The patient was unhappy with the iol and complained of glare/halos and "beams/rods of light at night" making driving at night difficult.The patient stated it started from the beginning of the implant and has tried to overcome visual issues.Another johnson & johnson diu150 lens (different model and higher diopter) was implanted as a replacement.There was no patient injury.No ocular complaints at first post-operative visit after lens exchanged, the patient ended up with 20/25 without correction vision.No further information is available.
Additional Manufacturer Narrative
Patient weight and ethnicity: unknown as information was not provided.The intraocular lens (iol) has not returned for evaluation; therefore, failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Patient weight and ethnicity: unknown as information was not provided.The intraocular lens (iol) has not returned for evaluation; therefore, failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a synergy intraocular lens (iol) was explanted from the patient's right (od) eye.The patient was unhappy with the iol and complained of glare/halos and "beams/rods of light at night" making driving at night difficult.The patient stated it started from the beginning of the implant and has tried to overcome visual issues.Another johnson & johnson diu150 lens (different model and higher diopter) was implanted as a replacement.There was no patient injury.No ocular complaints at first post-operative visit after lens exchanged, the patient ended up with 20/25 without correction vision.No further information is available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: return to manufacturer: 2/28/2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: product evaluation was performed under magnification.The complaint lens was received cut in half.No issues related to or could have contributed to visual issues were observed.No handpiece was received as part of this return therefore, no product evaluation could be performed on the handpiece.Based on the return condition of the lens, the complaint issue could not be confirmed, and no product deficiency could be identified.Conclusion: as a result of the investigation, there is no indication of a quality product deficiency and the reported issue could not be verified.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: 13563847
• Report Number: 3012236936-2022-00439
• Device Sequence Number: 1957399
• Product Code: MFK
• UDI-Device Identifier: 05050474751194
• UDI-Public: (01)05050474751194(17)240330
• 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: 2021
• 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
• Report Date (Section B): 03/28/2022

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: 03/30/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U165
• 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: 02/02/2022
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• 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: Male