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 Code	Blurred Vision (2137)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is (b)(6) 2020 as it was indicated by the doctor that the event observed first in (b)(6) 2020.If explanted, give date: not applicable as the device remains implanted (other): the intraocular lens (iol) is not returning 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 the 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 initially reported that a patient received an intraocular lens (iol) implant in the right eye on (b)(6) 2007 and was recently examined.The doctor observed white deposits within the iol.He was sure they are in the iol because he attempted to yag (yttrium-aluminum garnet) them off and they could not be moved.The capsule was opened.Further information was later provided, the patient came in for a follow up and complained of blurred vision.It was indicated that the symptoms had been present for at least six (6) months.Upon evaluation, the doctor observed white deposits within the lens.The event was observed by the doctor in (b)(6) 2020.At first, the doctor thought that the issue was posterior capsule opacification (pco), but during the yag which was performed at the end of (b)(6) 2020, it was apparent that the iol had deposits and were not being moved by the yag.The doctor indicated that during the yag, he could tell that the posterior capsule was opened and that the deposits were not related to the capsule.The acuity in the affected eye is 20/40.It was reported that the patient is still functional and can perform their daily activities such as driving.The patient has had no other surgery in the right eye and the other eye (left eye) was reported to be fine.It was indicated that lens is still in the patient¿¿s right eye, and no surgery is being entertained at this time.The doctor plans on observing it for now.No further information was provided.

• 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
• MDR Report Key: 11319196
• Report Number: 2648035-2021-07246
• Device Sequence Number: 19868523
• Product Code: HQL
• UDI-Device Identifier: 05050474501522
• UDI-Public: (01)05050474501522
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2012
• Device Model Number: CLRFLXC
• Device Catalogue Number: CLRFLXC185
• 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: 01/05/2021
• Initial Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention