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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age:unknown, not provided.Weight: unknown, not provided.Ethnicity: unknown, not provided.Date of event is unknown.The best estimate time would be (b)(6) 2021, as the surgeon indicated 1 month post-op examination when patient complained of having visual symptoms.Date of explant is unknown/ information not provided.Initial reporter email address: unknown, not provided.The intraocular lens (iol) is not returning for evaluation as it was discarded; 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, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient ended up ou 20/20 j1, but could not tolerate glare and halo after the implantation of the synergy intraocular lenses (iols) in both eyes (ou).The lenses were removed and replaced with non-johnson and johnson monofocal lenses after the 1-month post-op appointment.The explanted iols were discarded and are not available for return.No further information is available.This report represents the left (os) eye.A separate report will be submitted for the right (od) eye.
Additional Manufacturer Narrative
Age:unknown, not provided.Weight: unknown, not provided.Ethnicity: unknown, not provided.Date of event is unknown.The best estimate time would be (b)(6) 2021, as the surgeon indicated 1 month post-op examination when patient complained of having visual symptoms.Date of explant is unknown/ information not provided.Initial reporter email address: unknown, not provided.The intraocular lens (iol) is not returning for evaluation as it was discarded; 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, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient ended up ou 20/20 j1, but could not tolerate glare and halo after the implantation of the synergy intraocular lenses (iols) in both eyes (ou).The lenses were removed and replaced with non-johnson and johnson monofocal lenses after the 1-month post-op appointment.The explanted iols were discarded and are not available for return.No further information is available.This report represents the left (os) eye.A separate report will be submitted for the right (od) eye.

• Brand Name: TECNIS IOL
• Common Device Name: 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: 13511721
• Report Number: 3012236936-2022-00359
• Device Sequence Number: 17239427
• Product Code: HQL
• UDI-Device Identifier: 05050474750555
• UDI-Public: (01)05050474750555(17)240401
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2022

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: 04/01/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU140
• 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: 01/21/2022
• Initial Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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