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

Model Number	ZA9003
Medical Device Problem Codes	Material Discolored (1170); Material Opacification (1426)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information unknown/not provided.If explanted, give date: not applicable as the device remains implanted.Phone number: (b)(6).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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient complained of foggy/blurry vision in their left eye and that the implanted intraocular lens (iol) was cloudy on (b)(6) 2021 post-operation.The doctor commented that whitening/glistening of lens may have occurred.No loss of vision problem has been observed and the visual acuity (va) was reported to be 1.2.It was indicated that the lens remains implanted.The visual acuity (va) before the surgery was 1.0 and the target refraction of surgery was emmetropia.The lens was implanted at another clinic on (b)(6) 2009 and there was no problem when it was inspected at the clinic on (b)(6) 2021.Reportedly, the doctor will consider replacing the lens if the patient's eyesight deteriorates, but at this point the doctor will observe the progress.No further information was provided.
Additional Manufacturer Narrative
Additional information: the customer photos were reviewed by the johnson and johnson subject matter expert (sme), which determined that "the origin of the lens haziness as well as its potential clinical impact cannot be determined from a picture evaluation".All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• 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: 12014398
• Report Number: 2648035-2021-08020
• Device Sequence Number: 3304316
• Product Code: HQL
• UDI-Device Identifier: 05050474529069
• UDI-Public: (01)05050474529069(17)140318
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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: 03/18/2014
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 09/14/2021
• 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: Other
• Patient Age: 69 YR