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

Model Number	DFW150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device 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 an intraocular lens (iol) was explanted from the patient's right eye due to blurry vision.Account indicated that patient could not see street signs or television clearly at 1 week post iol implantation and vision fluctuated as well as the manifest refraction.Once refraction was stabilized patient decided on yttrium aluminum garnet (yag) capsulotomy hoping it would help.But in the end patient still unsatisfied, hence doctor explanted the iol.Pre-operative visual acuity 20/60, post-operative 20/30 -2.It was provided that the incision was enlarged during the explant.Explanted lens was replaced with a different model and diopter iol (model zcu225, 17.0 d).There was no patient injury reported.No further information was provided.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes.Returned to manufacturer on: may 23 2022.Section h3.Device evaluated manufacturer? yes.Device evaluation: visual inspection under magnification revealed that the lens was received coated in viscoelastic residue.The lens was cleaned and, no issues that could cause or be related to blurry vision or treatment via yag could be identified.The complaint issue could not be confirmed.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation there is no indication of a product quality 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
• 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: 14308094
• Report Number: 3012236936-2022-01207
• Device Sequence Number: 5223222
• Product Code: MFK
• UDI-Device Identifier: 05050474751224
• UDI-Public: (01)05050474751224(17)240710
• 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
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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: 07/10/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U180
• 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: 04/26/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2021
• 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: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White