MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE - IRELAND ACUVUE® 2®; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number AV2

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

Patient Problems Bacterial Infection (1735); Corneal Edema (1791); Corneal Scar (1793); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Local Reaction (2035); Red Eye(s) (2038); Blurred Vision (2137); Visual Disturbances (2140); Excessive Tear Production (2235); Eye Pain (4467)

Event Date 08/11/2021

Event Type  Injury  

Manufacturer Narrative

Suspect product discarded.

Event Description

On (b)(6) 2021 a patient (pt) in (b)(6) called to report a diagnosis of 3 od corneal ulcers in (b)(6) 2021 while wearing the acuvue® 2 brand contact lens (cls).The pt reported symptoms of swelling, redness, tearing, burning sensation and pain.The pt reports sleeping in the cls and has a 1 to 1 ½ month replacement schedule.On 15dec2021 the pt provided additional information, medical reports, and picture of lot number.-ecp statement dated 13aug2021; ¿the pt was referred due to corneal ulcers after improper use of cl.Refers to sleeping in lenses, dirty, for 3 consecutive days.Forwarded to perform scraping.¿ exam od: va: 20/200 bio: od presence of 3 lower and 3 upper paracentral lesions 0.6 (h) x 0.7 (v) more de-epithelized with other being smaller, apparently circular 0.2 x 0.2.Corneal edema 2+/4+.Conjunctival hyperemia 2+/4+, ciliary injection.Diagnosis: corneal ulcer due to acanthamoeba ? -lab report dated (b)(6) 2021 gram cytobacterioscopy: presence of rare gram-negative rods per field.Average of 11 polymorphonucleated leukocytes per field.Fungus: negative aerobic bacteria: isolated pseudomonas aerugionosa, scant growth.1.Prescription dated (b)(6) 2021: vigamox 1 drop every hour for 10 days.Hyabak 1 drop 8 times daily or as needed.Return (b)(6) 2021 2.Prescription illegible.3.Prescription dated (b)(6) 2021: vigamox every 4 hours od until evaluation.Hyabak 1 drop multiple times per day as needed for ocular discomfort.Tobracin 1 drop every 4 hours until return.4.Prescription dated (b)(6) 2021: vigamox 1 drop every 4 hours od until medical evaluation.Hyabak 1 drop multiple times per day as needed for discomfort.Tobracin 1 drop every 4 hours until return.Return (b)(6) 2021 5.Prescription dated (b)(6) 2021: vigamox 1 drop every 4 hours od until medical evaluation.Hyabak 1 drop as needed for discomfort.Tobracin 1 drop every 4 hours until return.Return (b)(6) 2021.6.Prescription dated (b)(6) 2021: vigamox 1 drop every 4 hours od until medical evaluation.Hyabak or optive 1 drop as needed for discomfort.Predfort or maxidex 1 drop every 12 hours until return.Return on (b)(6) 2021.7.Prescription dated (b)(6) 2021: lubricating drops 1 drop qid.Ster/predford/oftpred/maxidex 1 drop every 6 hours for 7 days; 1 drop every 8 hours for 7 days; 1 drop every 12 hours for 7 days.Return on (b)(6) 2021.8.Prescription dated (b)(6) 2021: hyabak/lacrifilm 1 drop oid, continuous use and prn irritation, burning sensation, itching.Tacrolimus (antineoplastic and immunomodulators) 1 drop od every 12 hours for 1 month.Return in 1 month.On 15dec2021 the pt provided additional information.The pt reported the symptoms began on (b)(6) 2021 on awaking with red od.The pt visited an urgent care clinic on (b)(6) 2021 and then referred for a consult at a specialty eye clinic on (b)(6) 2021.On removal of the suspect od cls, the od was red, painful, photophobic with tearing and blurry vision.The pt clarified the illegible prescription was dated (b)(6) 2021 for vigamox 1 drop every hour for 10 days.Hyabak 1 drop every 8 hours or as needed.The pts od symptoms didn¿t improve for a ¿very long time.¿ the od is ok now with slight swelling.On the last doctor visit, about 15 days ago, the pt was advised there is od corneal scarring due to the ulcers.The pt advised the od prescription didn¿t change with new refraction (date of the refraction not provided).The pt did not trial fit with the doctor for the suspect cls.The pt is released to return to cls wear.The doctor advised the pt to wear acuvue oasys brand contact lenses due to increased oxygenation with no sleeping in the cls.No additional medical information has been received.A lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot l003g7v was produced under normal conditions.The od suspect cls was discarded.No additional evaluation can be conducted.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE® 2®
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE - IRELAND; 1 technological park plassey; limerick LK130 01; EI LK13001
• Manufacturer Contact: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433835
• MDR Report Key: 13191001
• MDR Text Key: 288590602
• Report Number: 1057985-2022-00001
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/07/2022

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2023
• Device Catalogue Number: AV2
• Device Lot Number: L003G7V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2018
• 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): Other; Disability; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female