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Catalog Number FAL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Edema (1791); Deposits (1809); Vitreous Floaters (1866); Headache (1880); Iritis (1940); Itching Sensation (1943); Local Reaction (2035); Blurred Vision (2137); Visual Disturbances (2140); Corneal Infiltrates (2231); Excessive Tear Production (2235); Eye Pain (4467)
Event Date 06/07/2021
Event Type  Injury  
Manufacturer Narrative
The suspect lens was discarded.
Event Description
On (b)(6) 2021 a patient (pt) called to report an od bacterial infection while wearing a trial pair of acuvue® oasys multifocal contact lenses (cls). The pt began wearing the trial lens on (b)(6) 2021 provided by the eye care providers (ecp) office. The pt reported the vision was not clear and began to experience photophobia and pain on (b)(6) 2021. The pt went to the ecp on (b)(6) 2021 and was prescribed tobramycin/dexamethasone suspension 1 drop in the od every 2 hours, while awake for 2 days, then 1 drop qid for 8 days. The pt advised there is no follow-up appointment with the ecp as the ecp advised the eye drops prescribed should resolve the issue. The pt reported the photophobia has resolved, but advised the od is still tearing and the eyelid is swollen. The pt reported daily cls wear and noted nothing visibly wrong with the suspect od cls. On (b)(6) 2021 a call was placed to the pts treating ecp for additional medical information. A representative advised the ecp was out of the office and will return tomorrow. On (b)(6) 2021 the pts treating ecp provided additional medical information. The ecp advised the pt was diagnosed with od inflammation, not a bacterial infection. The treatment was verified as previously reported by the pt. The ecp advised the treatment is standard of care, especially to treat discomfort. The pt was not advised to return for a follow-up visit. The pts od event was reviewed and determined to be a not reportable event to the fda with the additional information provided by the pts treating ecp. On (b)(6) 2021 a call was placed to the pt who provided additional medical information. The pt has returned to the ecp 4 times and was prescribed 4 medications. The pt has a follow-up appointment on (b)(6) 2021 with a specialist. The pt was diagnosed with (kp) keratic precipitates. The pt was getting deposits on the cornea, swollen cornea, headaches, blurriness, floaters and glare with unclear vision in the od only. The pt was prescribed prednisolone acetate (unknown treatment details). The pt reported the symptoms were resolving but came back, the treating ecp didn¿t know why. On (b)(6) 2021 the treating ecp reported the pt was diagnosed with iritis with keratic precipitates not resolving after a few weeks of steroid treatment. The pt is being referred to ophthalmology for additional treatment and may need blood tests to determine the cause. The ecp confirmed the pt was prescribed prednisolone qid for several weeks as standard treatment for iritis. The pt has no scarring noted, just corneal edema. The pts od event was re-evaluated with the additional medical information provided by the treating ecp and determined to be a serious medical reportable event to the fda. On (b)(6) 2021 the ecp provided the pt medical records. The notes indicate pt¿s diagnosis is iritis od with kp and corneal edema od. The pt was referred to ophthalmology for evaluation and treatment on (b)(6) 2021 as the pt was not improving with prednisolone 1% qid od treatment. The ecp notes state the pt was unable to drive comfortably with blurred vision od. Date of visit: (b)(6) 2021. The pt reported upon insertion of a new pair of lenses on (b)(6) 2021 the od was light sensitive, the pt also felt sharp pain, tearing, itching and redness. The pt was diagnosed with (clare) contact lens-induced acute red eye od. The pt was asked to discontinue cls wear, discard cls and the cls case. The pt was prescribed tobradex q2h for 2 days, then qid od. Date of visit: (b)(6) 2021. The pt reported symptoms not getting better, drops helped with pain, vison worsening with film over eye. The pt¿s visual acuity (va) with glasses was od 20/60. The pt was diagnosed with iritis od with kp. The pt was prescribed prednisolone acetate 1 drop qid od for 1 week. Date of visit: (b)(6) 2021. The pt reported the eye is not better, blurry vision and ¿blobs in vision like raindrops on windshield. ¿ diagnosis: iritis od with reduced no kp and corneal edema. Pt¿s corrected va was od 20/50-. Date of visit: (b)(6) 2021 the pt complains of daily headaches, floaters in od, vision still blurry, film, and the eye feels swollen. The pt stated the drops helped. The diagnosis of iritis with kp not resolving. The pt¿s corrected va was od 20/200. The pt was instructed to continue prednisolone od and was referred to ophthalmology. On (b)(6) 2021 a call was placed to the pt for additional medical information following the ophthalmology visit, but nothing additional was received. No additional medical information has been received. The lot number of the od suspect cls is unknown. The suspect od cls was discarded. No additional evaluation can be conducted. 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 Key12241726
MDR Text Key268223983
Report Number1057985-2021-00145
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberFAL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/28/2021 Patient Sequence Number: 1