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

Model Number	CLRFLXC
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Codes	Foreign Body Sensation in Eye (1869); Visual Disturbances (2140)
Date of Event	06/23/2009
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d6a.If implanted, give date: unknown, information not provided, but the best estimate date is 2009.Section d6b: if explanted, give date: not applicable as the device remains implanted.Section h3 (no): 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 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.Attempts have been made to obtain additional information regarding the event; 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
A patient who had clariflex lenses implanted in both right (od) and left (os) eyes in 2009 reported of experiencing significant vision issues due to deposits that have formed on the intraocular lenses (iols).The symptoms significantly interfere with daily activities of patient.The lenses remain implanted.On (b)(6) 2009 (onset): the patient states os visual acuity (va) seems great.Feels like foreign body (fb) and little flickery.Manifest refraction -1.25 + 0.50 x 130, 20/30.Visually significant cataract (vsc): 20/50 -2, pinhole (ph) 20/40.On (b)(6) 2009: the patient states va is clearer in both eyes (ou), complaint of left eye (os) having a foreign body sensation (fbs) on outer edge at times.Without correction va <20/25-1; 20/60-2, ph 20/30-2 without correction j-2.Sle (slit lamp evaluation) minor folds.Meds as directed for both eyes (systane ultra tears).As a result, the patient is scheduled for a procedure to exchange the iols and implant new lenses.A retina specialist is to exchange the iols and suture in new lenses.No further information was provided.This emdr report pertains to the right eye (od) of the patient.A separate report will be submitted for the patient's left eye (os).·.

• Brand Name: CLARIFLEX
• 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: 21099450
• Report Number: 3012236936-2025-000007
• Device Sequence Number: 21037302
• Product Code: HQL
• UDI-Device Identifier: 05050474501638
• UDI-Public: (01)05050474501638(17)140109
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2014
• Device Model Number: CLRFLXC
• Device Catalogue Number: CLRFLXC240
• 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: 12/13/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2009
• 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
• Patient Age: 55 YR
• Patient Sex: Female