MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number DFW150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Flashers (1864); Foreign Body Sensation in Eye (1869); Intraocular Pressure Increased (1937); Red Eye(s) (2038); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Patient weight and ethnicity/race: unknown, asked but not available date of event: unknown, not provided, but the best estimate date is (b)(6) 2023.Other 81: the device was not returned for evaluation.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.Health effect - impact code: 4644 - medication required- used to indicate the medical intervention and topical steroids.Health effect - clinical code: 4581- eye anatomy issue.Health effect - clinical code: 2137- blurred vision- used to indicate blurred vision and poor near vision.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that patient had cataract procedure and lens was implanted in left eye on (b)(6) 2022 and femto was used.On one day post operative examination, patient was taking prednisolone/moxifloxacin four times a day in left eye.Patient stated eye was irritated on the night of surgery that it was blurry and she kept it closed.Patient was asked to continue using prednisolone/gatifloxacin four times a day.Patient was asked to begin using predforte artificial tears in both eyes as needed.Patient was asked to begin using combigan twice a day to address the elevated intraocular pressure.On second post operative examination on (b)(6) 2022, patient stated that she was feeling like a light is flashing on left eye.Patient still using prednisolone/gatifloxacin drops for times a day.Patient was asked to taper prednisolone/gatifloxacin to twice a day in left eye.Could consider removing suture at next visit.On third post operative examination on (b)(6) 2022, patient stated that she was still seeing blurry and still seeing flashes of light.Flashes look like lightning and some lights have halos around them and still could not see small print and wearing shades because of light sensitivity.She reported the prednisolone/moxifloxacin twice a day in left eye burns when used.Patient reported to had to close her eye to watch tv sometimes because she feels pain.Patient mentioned at times feels cross-eyed, she sees double at times when she's outside.Patient was tested for diplopia (noted 2 bo right eye).Patient was ok to discontinue prednisolone/gatifloxacin.New glasses prescription given to patient.On fourth post operative examination on (b)(6) 2022, patient stated that she still has blurry visual acuity (close and distance) as it felt like looking through a smudge.Left eye feels foreign body sensation and gritty.She constantly sees light / halos through left eye.After last visit she ordered new glasses but they have not arrived yet.Patient was instructed to discontinue prednisolone/moxifloxacin after last visit.Patient was asked to take pred-acetate four times a daily for 1 week, then taper to twice for 1 week.On fifth post operative examination on (b)(6) 2022, patient stated that she could not use new glasses because eye was still blurry, worried about her driving.Stated that she could not walk with her glasses because it's blurry.Stated that lights look scattered and sees lights and halos.Stated she could not wear glasses for reading for a long time.She was tested for double vision and noted 5 bo.5 bu os.(anisometropia).Removed os suture.Patient eyes have healed well.Patient was asked to continue pred twice a day for one more week then discontinue.Patient stated prior to surgery did not walk with glasses, patient was asked not to not walk with glasses if it is causing her trouble.Ok to use glasses for near and small print as needed.Could consider having just a reading prescription.On sixth post operative examination on (b)(6) 2022, patient stated vision was still blurry.Patient stated lights were scattered and has to wear sunglasses to drive during the day and at night.Stated that she uses magnifiers for near work, her glasses weren't giving her clear vision.Oct mac results were normal.Patient not doing well with multifocal.Iol exchange with a single focus lens for distance, risks, hazards, and benefits were discussed with patient.Patient to schedule iol exchange os.Target: plano.On (b)(6) 2023, the implanted lens was explanted from left eye.The lens was replaced by an intraocular lens model diu150 +24.00.On one day post operative examination of diu lens implantation occurred on (b)(6) 2023, patient denied any pain/discomfort.Using prednisolone/moxifloxacin four times a day.On second post operative examination of diu lens on (b)(6) 2023, patient denied any pain/discomfort.Patient was asked to taper prednisolone/moxifloxacin to twice a day on (b)(6) 2023.On third post operative examination of diu lens on (b)(6) 2023, patient complained of slight pain when she closes her left eye, also reported something coming down like a shade over the left eye for the last couple of weeks from the date of examination.Fundus photos were planned to be taken on that day.Patient was asked to continue prednisolone/moxifloxacin twice a day for one week then stop.On fourth post operative examination of diu lens on (b)(6) 2023, patient was having more pain in left eye since she stopped using the prednisolone/moxifloxacin drops.Patient reported that started taking the drops again since yesterday (the day before the examination ¿ (b)(6) 2023) in both eyes but that on the day of examination she only used the drops in the left eye.She reported left eye had foreign body sensation, irritated and pain when she closes it.Temporal crescent was noted but indicated that it has been improving.Patient was asked to continue using prednisolone/moxifloxacin twice a day for a week and then every day for a week and then discontinue.Patient informed that temporal crescent could take up to 1-2 months to clear.On fifth post operative examination on 01/31/2023, patient was still using prednisolone/moxifloxacin every other day/sometimes.Patient said her eyes felt like sand in the morning and dry at night.Patient doesn't wear glasses anymore.Patient still has flashes and floaters.No new glasses prescription given.Patient was asked to discontinue prednisolone/moxifloxacin.Recommended using artificial tears for dryness.

• Brand Name: TECNIS IOL
• Type of Device: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16456654
• MDR Text Key: 310409335
• Report Number: 3012236936-2023-00524
• Device Sequence Number: 1
• Product Code: MFK
• UDI-Device Identifier: 05050474751347
• UDI-Public: (01)05050474751347(17)240610
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Race: Asian