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

Model Number	NXG1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Posterior Capsule Opacification (4807)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: date of event: unknown, not provided, but the best estimate date is after may 27, 2008.Section d6b: if explanted; give date: not applicable as the device remains implanted.Section h3: the device was not returned for evaluation as the lens remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending will be performed.Upon completion of this review, if there is any further relevant information, a supplemental medwatch will be filed.Section h6: health effect - impact code: 4625 yag (yttrium aluminum garnet).Attempts have 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 a patient is experiencing difficulty seeing small numbers with implanted intraocular lenses (iol) in both eyes.The patient reported that a doctor who is no longer at the facility had periodically lasered off a film that developed on the eyes after the initial implant surgeries, which resolved the issue in the past.The new doctor at the facility has advised the patient to use glasses instead of performing the same procedure.The patient reported being able to see larger objects well and is generally satisfied with overall vision.The patient reported a history of diabetes and dry eye but has never been informed that either condition was affecting the vision.No further information was provided.The patient had bilateral lens implantation.This report is for the right eye.A separate report will be submitted for the left eye of the patient.

• Brand Name: REZOOM 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: 23789974
• Report Number: 3012236936-2025-000333
• Device Sequence Number: 5712750
• Product Code: MFK
• UDI-Device Identifier: 05050474520295
• UDI-Public: (01)05050474520295
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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: 01/31/2012
• Device Model Number: NXG1
• Device Catalogue Number: NXG1BU0215
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2007
• 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