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 Impairment (2138); Visual Disturbances (2140)
Date of Event	02/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returned as lens remains implanted; 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 a patient had bilateral intraocular lens (iol) implants.But the right eye lens is planned to be removed on (b)(6) 2022 due to glare, blurry (cloudy) vision and light sensitivity with loss of 2 or more lines of bscva (best spectacle corrected visual acuity).It was indicated that both eyes are impacted and that the symptoms significantly interfere with patient's daily activity.No medical or surgical interventions were reported.No other information was provided.This report pertains to the patient's right eye.A separate report will be submitted for the left eye.
Additional Manufacturer Narrative
Additional information: upon further review it was missed to code for section h6: health effect impact code: explant in the 1st supplemental mdr.This follow-up mdr is to capture this code.Field below updated.Section h6: health effect impact code: explant.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that loss of 2 or more lines of bscva was not coded in h6: health effect clinical code (2138).Hence, this correction submission.Additional information: new information received that suspect lens in right eye, scheduled on (b)(6) 2022 did occur on that date.No adverse events, patient was in stable condition.Explanted product not being returned.Replacement lens same model as original lens.No other information was provided.Field below updated: section d6b: if explanted, give date: (b)(6) 2022.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: 14810714
• Report Number: 3012236936-2022-01589
• Device Sequence Number: 12001935
• Product Code: MFK
• UDI-Device Identifier: 05050474751309
• UDI-Public: (01)05050474751309(17)240918
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/15/2022

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: 09/18/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U220
• 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: 06/03/2022
• Supplement Date Received by Manufacturer: 08/11/2022; 08/15/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 08/12/2022; 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2021
• 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: Other
• Patient Sex: Male