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Catalog Number ATL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Local Reaction (2035); Red Eye(s) (2038); Uveitis (2122); Blurred Vision (2137); Visual Disturbances (2140); Excessive Tear Production (2235); Eye Pain (4467)
Event Date 05/01/2021
Event Type  Injury  
Event Description
On (b)(6) 2021 a johnson and johnson sales representative reported a patient (pt) in singapore experienced eye inflammation and was referred to an eye specialist while wearing the acuvue¿ vita" brand contact lens (cls). The pt did not experience discomfort prior to wearing the suspect lens. No additional medical information was provided. On (b)(6) 2021 a call was placed to the eye care provider (ecp) for additional medical information. A representative advised the pt was an experienced wearer and provided the affected lot # b00tjzg. The event date is (b)(6) 2021. On (b)(6) 2021 the pt provided additional information. The pt reported wearing the vita cls for about 3 years. The pt reported od inflammation, blurry vision, sensitivity to light, soreness and pain and was prescribed steroid medication. The pt has a follow-up appointment with the treating ecp and reported the od is recovering. The cause of the event was undetermined. The pt wore the suspect od cls for less than a week when the symptoms began. The pt reported 2 days of mild discomfort on wednesday and thursday, then sought medical attention on friday and was prescribed chloramphenicol eye drops. The eye condition was worse on sunday and the pt stopped using the eye drops. The eye became more swollen with redness which used to be on one corner is now around the whole eye. The pt reported blurry vision and tearing on monday evening and on tuesday the pt went back to the ecp and was referred to a&e. The pt reported daily cls wear and used bausch and lomb sensitive formula cleaning solution. On (b)(6) 2021 an email was received from the ecp who advised the pt experienced discomfort and eye inflammation od after 4-5 days of wearing the new cls. The pt is currently wearing spectacles. The pt is an experienced vita brand cls wearer for 3 years. On (b)(6) 2021 the (b)(6) affiliate reported the medical report was requested, but the pt didnt have it on hand. The diagnosis of anterior uveitis od was provided. On 31may2021 additional information was provided by the pt. The pt reported the doctors diagnosed an autoimmune condition that is not a secondary effect from contact lenses usage. On (b)(6) 2021 additional information was provided by the pt. The pt reported a follow-up visit on (b)(6) 2021 and was tested for hla-b27 gene; no results were provided. The pt provided the doctors referral to ophthalmology and a medication list. Referral note to ophthalmology received on (b)(6) 2021 (no date of visit provided): referral to ophthalmologist. Pt referred with a painful and teary red eye (affected eye not provided). The pt had uv radiation accidently to the eyes during a facial treatment just prior to symptoms. The pt was prescribed chloramphenicol eye drops last friday. Today symptoms are worse, pt complains of blurry eye; handwritten additional comments: photophobia +, red eye + and pain and illegible wording. O/e alert; va-r 6/9. 5 -1; right eye swelling over upper eyelid, very inflamed conjunctiva and ? uveitis cornea seems clear; reactive to light imp  red and painful  ? cause manage and arrange eye consult. Medication list received (b)(6) 2021: prednisolone 5mg tablet; 40 mg every morning; 2 days, then. Prednisolone 5mg tablet; 30 mg every morning; 7 days, then. Prednisolone 5mg tablet; 20 mg every morning; 7 days, then. Prednisolone 5mg tablet; 10 mg every mon morning; 7 days, then. Prednisolone 5mg tablet; 5 mg every morning; 7 days. Po omeprazole 20 mg every morning; 2 months. Calcium and vit d (450mg/200iu) 450/200iu, 1 tablet every morning; 2 months. Ophthalmic pred forte 1% eye drop; 1 drop r/e qid; 1 month/1 bottle. Additional information was requested from the pt. No additional 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 b00tjzg was produced under normal conditions. One open contact lens case containing two contact lenses for lot # b00tjzg, were received from the patient. The parameters of the two opened lenses were measured, and a visual inspection was performed. The two opened lenses met company standards for base curve, sphere power, center thickness, and diameter. No visual attributes were observed. Five sealed blisters for lot # b00tjzg were also received. The solution for the five sealed blisters were measured for ph and conductivity and were within specification. If any further relevant information is received, a supplemental report will be filed.
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Manufacturer (Section D)
7500 centurion parkway
jacksonville FL 32256
Manufacturer Contact
rose harrell
7500 centurion parkway
jacksonville, FL 32256
MDR Report Key11983783
MDR Text Key266412081
Report Number1057985-2021-00137
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberATL
Device Lot NumberB00TJZG
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/16/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/11/2021 Patient Sequence Number: 1