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

Model Number	DFR00V
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); Halo (2227)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was implanted into the patient¿s ocular sinister (left eye).Patient complains of blurry vision in distance and intermediate and having hard time watching television.Patient had inadequate vision for driving and patient was having a hard time seeing street signs until almost past them and glare coming from headlights.Glare also happens with artificial light and sunlight.Halos both night and day and left eye had double vision.Glasses did not help.Iol explant scheduled for (b)(6) 2023.Through follow-up, additional information was received that the iol was explanted from the patient¿s ocular sinister in a secondary surgical procedure and replaced with a another johnson & johnson lens, model dib00 20.0 diopter.There was no incision enlargement, no serious patient injury, no suture(s), and no vitrectomy.Patient outcome post-lens exchange was reported as patient doing well at 1-day post-operatively.The explanted iol is not available for return as it was discarded.No further information is available.
Additional Manufacturer Narrative
Section h6: health effect - clinical code: 2140 -visual disturbance- dysphotopsia, 2140 glare.Device evaluation: product evaluation was not performed because the product has not been received; it was reported the explanted iol was discarded.If product is received after initial closure, the pi and cp (if necessary) may be re-opened to complete the return investigation.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.No nc/er was found as part of this manufacturing records review.A search of complaints revealed that two (02) additional complaint folders were found as part of this production order (po) number; and these complaint issues reported were not related.Based on complaint history review (chr) results, no escalations are required.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.

• 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: 17294338
• Report Number: 3012236936-2023-01522
• Device Sequence Number: 19886340
• Product Code: MFK
• UDI-Device Identifier: 05050474750678
• UDI-Public: (01)05050474750678(17)240921
• 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: 2022
• Device Explanted Year: 2023
• 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): 07/10/2023

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: 09/21/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU200
• 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: 06/16/2023
• Initial Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White