MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; MONOFOCAL IOLS

Model Number ZA9003

Device Problem Calcified (1077)

Patient Problems Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Vitreous Detachment (2445); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If implanted; give date: unknown/not provided.If explanted; give date: n/a (not applicable).To date, the lens remains implanted, however and exchange is planned.(b)(4).The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, 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 Description

It was reported that customer observed calcified model za9003 21.5 diopter tecnis monofocal iol (intraocular lens) after implanting in patient's right eye (od).This is reportedly due to aqueous makeup in patient's eye, but not necessarily in lens material.Through follow-up, patient's od has early calcification changes.Current visual acuity is 20/30.The doctor felt that these events are related to the lens itself, but rather to the metabolism of the patient.The doctor reported he will do an exchange in the near future.No additional information provided.This report pertains to right eye.A separate report will be submitted for the left eye.

Manufacturer Narrative

Corrected data: in review of the initial mdr, a correction was noted because a photographic evaluation was inadvertently not included in the initial report.Photograph evaluation: photos were provided for the implanted lens.Something like white spots were observed; however, it was not possible to determine if they are on the anterior lens surface or at the posterior of the lens.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

This supplemental report pertains to right eye (od).A separate report will be submitted to left eye (os).Based on new information received, the (b)(6) female patient had bilateral 3-piece silicone lens implants in 2007, surgeries were uneventful, patient's visual acuity post-op was 20/20.She had a history of elevated calcium, workup was unremarkable with no etiology identified.The doctor felt to be secondary to the excessive calcium intake combined with vitamin d supplements.In 2016, patient was referred for posterior capsule opacification with symptoms included difficulty in reading and reading road signs.Patient's visual acuity was 20/50 od.Prescribed medications in 2016 were atorvastatin, digoxin, losartan, omeprazole, kcl, triamterene/hctz, and zyrtec.The patient underwent iol exchange od finally followed by os.The silicone lens was lens was cut, removed from capsular bag and extracted.A replacement lens model, z9003 monofocal iol was placed in the capsular bag leaving a well-centered iol and clean bag.The surgery was uneventful.Her postop medications were topical antibiotic, steroid, topical nsai and a subtenon kenalog injection and her vision after the exchange was od -1.00 20/20.The patient maintained good vision until (b)(6) 2018.She was presented with complaints of decreased reading vision and night halos with visual acuity of 20/30 od.Slit lamp examination revealed posterior capsule opacification (pco) on both eyes (ou) as it appeared to be cloudiness on the posterior aspect of the lenses, especially in os.If explanted; give date: the date was not specified, but the best estimate date is during 2016 for od explant.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

Manufacturer Narrative

Additional info: this report is for model za9003 adverse event in the right eye.A separate report is being submitted to capture the reported za9003 adverse event in the left eye.The following article was received based on a literature review: article: surface deposits mimicking calcification on a hydrophobic acrylic intraocular lens further information was provided and reported in november 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.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.Through follow-up, it was learned that the right eye has a slight haze on the posterior lens which is believed to be a proteinaceous material.Capsule is intact with good vision.There were no surgical complications with the surgery.No further information is available.The following sections have been updated accordingly: section a2: age/date of birth: 3/8/1957 section 5a: ethnicity: not hispanic or latino section 5b: race: white section b6: relevant tests/laboratory data, including dates: history of elevated calcium with no etiology identified, suggested to be attributable to calcium intake combined with vitamin d supplements.High cholesterol, hypertension, arrhythmia, heartburn, and allergy.Patient has also been a heavy smoker, with one pack of cigarettes per day.Section b3: date of event: unknown, not provided.Best estimate of date of event is in 2018.Section d6: if implanted, give date: surgeon reported 10/24/2016, however, patient implant card states 10/19/2016.Section d7: if explanted, give date: not applicable, there is no indication the lens has been explanted.Section h6: patient code: 2140 visual disturbance- dysphotopsia, 3191 posterior capsule opacification, 2227 halo.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.A copy of the article is provided with this report.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 8210550
• MDR Text Key: 131888446
• Report Number: 2648035-2019-00002
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474529045
• UDI-Public: (01)05050474529045(17)210711
• Combination Product (y/n): Y
• PMA/PMN Number: P990080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/01/2005,04/28/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2021
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030215
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 01/02/2019
• Supplement Dates Manufacturer Received: 01/02/2019; 02/07/2019; 10/25/2020; 03/30/2021
• Supplement Dates FDA Received: 01/17/2019; 03/07/2019; 11/06/2020; 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR