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

Model Number ZA9003

Device Problem Material Opacification (1426)

Patient Problems Visual Disturbances (2140); Halo (2227); Vitreous Detachment (2445); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Weight: information unknown/not provided.Date of event: unknown, not provided.Best estimate of date of event is in 2018.If implanted, give date: surgeon reported (b)(6) 2016, however, patient implant card states (b)(6) 2016.Device evaluated by manufacturer (other): the intraocular lens (iol) is not returning for evaluation as it is discarded; 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.Werner, l., moulin, t., wallas, k., balendiran, v., shumway, c., ellis, n., mamalis, n.(2019).Surface deposits mimicking calcification on a hydrophobic acrylic intraocular lens.Journal of cataract & refractive surgery 45(7), pp.1036-1039.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The following article was received based on a literature review: article: surface deposits mimicking calcification on a hydrophobic acrylic intraocular lens.A case report was done to describe a patient who had hydrophobic acrylic intraocular lenses (iols) implanted and exhibited clinical postoperative findings that were suspicious for calcification under slit lamp evaluation.In 2007, a (b)(6) year-old female patient underwent uneventful cataract surgery in both eyes and implanted with 3-piece silicone iols tecnis z9002 (abbott medical optics, inc.).In nov 2018, the patient started reporting decreased reading vision and night halos.The patient's corrected distance visual acuity (cdva) was 20/30 in the right eye and 20/40 in the left eye.Slitlamp evaluation revealed pco in both eyes, and what appeared to be cloudiness, predominantly on the posterior aspect of the iols, especially in the left eye.As calcification was again suspected, another explantation/exchange procedure was performed in the left eye in jan 2019, with implantation of a 1-piece poly (methyl methacrylate) iol fixated within the bag.At 1 week post-op, no inflammatory reaction was observed in the left eye and the cdva was 20/30, yttrium aluminum garnet yag posterior capsulotomy was then performed.The cdva improved to 20/20 after the posterior capsulotomy.Clinical and optical coherence tomography examinations showed posterior vitreous detachment.The 3-piece hydrophobic acrylic iol explanted from the left eye was submitted for analyses in which protein deposits were identified in both anterior and posterior optic surfaces.Through follow-up, the implant date, explant date, and serial number was provided.The surgery was completed successfully using a non-johnson & johnson replacement lens.There were no surgical complications with the surgery.The capsule was intact.The lens was most likely discarded.The left eye had a yag capsulotomy about 4 months after the second exchange with good vision.No further information is available.This report is for model za9003 adverse event in the left eye.A separate report is being submitted to capture the reported za9003 adverse event in the right eye.

Manufacturer Narrative

Corrected data: upon further review, it was discovered that this event has been previously reported under manufacturer report number 2648035-2019-00001.Any additional reportable information received will be submitted under report number 2648035-2019-00001.No further information will be provided under this report number (2648035-2021-07683) as it has been determined to be a duplicate report.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11737597
• MDR Text Key: 263606973
• Report Number: 2648035-2021-07683
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P990080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention