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

Model Number ZA9003

Device Problem Calcified (1077)

Patient Problems 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 an exchange is planned for the near future.(b)(4).Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no additional complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that calcification was observed on a model za9003 21.0 diopter, tecnis monofocal iol (intraocular lens) after implant in patient's left eye (os).Reportedly, this is due to the aqueous makeup of the patient's eye, not necessarily in lens material.Through follow-up, patient's current visual acuity os is 20/40.The doctor felt that the findings were not related to the lens itself, but rather to the metabolism of the patient.The doctor reported he will do a lens exchange in the near future.No additional information provided.This report pertains to left eye.A separate report will be submitted for the right eye.

Manufacturer Narrative

This supplemental report pertains to left eye (os).A separate report will be submitted to right eye (od).Based on new information received, the (b)(6)-year-old 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 of difficulty in reading and reading road signs.Patient's visual acuity was 20/40 left eye (os); 20/50 right eye (od).Prescribed medications in 2016 were atosvastin, digoxin, losartan, omeprazole, kcl, triamterene/hctz, and zyrtec.The patient underwent iol exchange od 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 os plano 20/20.The patient maintained good vision until (b)(6) 2018.She presented with complaints of decreased reading vision and night halos with visual acuity of 20/40 os.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.As a result, os lens explant or exchange was performed on (b)(6) 2019 with implantation of a single-piece pmma (polymethyl methacrylate) lens fixated within the bag.During the last examination performed 1 week postoperatively, no inflammatory reaction was observed in os.Patient's bcva (best corrected visual acuity) os was 20/30 and a nd:yag posterior capsulotomy was scheduled.The explanted os lens was submitted to two different outside labs by the surgeon and was evaluated.Explanted os lens under the light microscope showed the presence of multiple deposits irregular in shape and size covering significant areas of anterior and posterior iol optic surfaces.The lens was further analyzed under environmental scanning electron microscopy (esem)which confirmed the presence of multiple irregular deposits, but the energy-dispersive x-ray spectroscopy (eds), which analyzes the elemental composition of surface deposits, did not detect the presence of any calcium (ca) or phosphorous (p) peaks.Hence, it ruled out the presence of calcification.If explanted; give date: the date was not specified, but the best estimate date was (b)(6) 2019 for os 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 (b)(4) and capa-010215.

Manufacturer Narrative

Additional info: 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.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 at 1 week post-op, the corrected distance visual acuity (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 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.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 12/05/2016, however, patient implant card states 11/9/2016.Section d7: if explanted, give date: 12/9/2019 section h6: patient code: 2227 halo, 2140 visual disturbance- dysphotopsia, 3191 posterior capsule opacification, 3191 yag, 2445 vitreous detachment 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: 8210494
• MDR Text Key: 131888513
• Report Number: 2648035-2019-00001
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474529038
• UDI-Public: (01)05050474529038(17)210630
• 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
• Report Date: 01/01/2005,04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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 Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR