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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE OASYS 1-DAY FOR ASTIGMATISM WITH HYDRALUXE TECHNOLOGY LENSES, SOFT CONTACT

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JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE OASYS 1-DAY FOR ASTIGMATISM WITH HYDRALUXE TECHNOLOGY LENSES, SOFT CONTACT Back to Search Results
Catalog Number TAS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Ulcer (1796); Dry Eye(s) (1814); Foreign Body Reaction (1868); Irritation (1941); Pain (1994); Red Eye(s) (2038); Swelling (2091); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2018 a patient (pt) called to report os discomfort as the lenses are not sitting well while wearing the acuvue oasys 1 day for astigmatism brand contact lenses. On (b)(6) 2018 the pt called to report the lenses felt ¿really dry¿ and irritated the eyes. The pt had difficulty removing the lenses and continued to experience discomfort. The pt was diagnosed with an ¿ulcer/infection¿ by the eye care provider (ecp) while the pt was out of state. The pt also advised the lenses for the os were misshaped. The pt saw an ecp on (b)(6) 2018. The pt also saw an ecp on (b)(6) 2018 on arrival back home. Event date was reported as (b)(6) 2018. On (b)(6) 2018 a call was placed to the pt and additional information was provided. The pt reported the corneal ulcer was diagnosed in the os. The pt experienced discomfort and advised the os was dry when the suspect contact lens (cls) was removed. The pt recalled the lens was more difficult to remove. The pt woke in the middle of the night with eye pain and foreign body sensation os. The pt was out of state and didn¿t have glasses and had to drive 5. 5 hours with cls on the os. The pt reported the os cls felt like a ¿band-aid¿ and the eye felt better with the lens in the os. The pt reported os eye pain after 7. 5 hours. The pt went to an eye care provider who advised the pt that the corneal ulcer ¿could have been caused by something under the cl or the cl itself; the ecp was not certain¿. Pt reported on the fourth day the ecp advised the pt that the os corneal ulcer was healing, but advised the pt to follow-up with an ecp on return home. Pt reported the os corneal ulcer has healed and pt was allowed to return to contact lens wear. On (b)(6) 2018 a call was placed to the pts treating ecp and additional information was provided: a representative reported the pt was diagnosed with an os corneal ulcer on (b)(6) 2018 and prescribed gatafloxacin q2h, prednisone bid and no contact lens wear. Pt returned for a follow-up visit the following day and was much improved. Pt was advised to finish gatafloxacin and taper prednisone. Pt was seen for follow-up visit the following day and was advised to discontinue the prednisone and decrease gatafloxacin to qid. Medical records received from the pts treating ecp on (b)(6) 2018. Date of visit: (b)(6) 2018. Va os w/o correction: 20/25; iop os: 12 mmhg. Slit lamp exam os: eyelids blepharitis; conjunctiva: 2+ injection; cornea: ulcer, peripheral; anterior chamber: moderate depth; iris: flat; lens: nuclear sclerosis 1+; 1 + edema. Impression: corneal ulcer os; pt is a contact lens wearer; start gatifloxacin q 1-2h; pred bid and recheck in 1 day; no contact lens wear. Date of visit: (b)(6) 2018. Va os: w/o correction: 20/20; iop os: 12 mmhg. Slit lamp exam os: eyelids: blepharitis; conj: 2+ injection; cornea: ulcer, peripheral; anterior chamber: moderate depth; iris: flat. Lens: nuclear sclerosis 1+; 1+ edema. Impression: corneal ulcer os; much improved; epi defect is closed and edema is much better. Will finish antibiotics and taper steroids. Date of visit: (b)(6) 2018. Va w/o correction: 20/25; iop: 13 mmhg. Slit lamp exam os: eyelids: blepharitis; conj: 2+ injection; cornea: ulcer, peripheral; anterior chamber: moderate depth; iris: flat; lens: nuclear sclerosis 1+; 1+ edema. Impression: corneal ulcer os; pt is cls wearer; will decrease gatafloxacin to qid until bottle is finished; slowly taper off ¿antibiotic¿. Medical records received from pts ecp on (b)(6) 2018. Date of visit: (b)(6) 2018. Chief complaint: pt was diagnosed with a corneal ulcer os while out of state on (b)(6) 2018; pt states today is a follow-up appointment; pt was using pa qid os and moxifloxacin q1h os, then qid. Pt not using pa drops anymore, but still using moxifloxacin qid os. Pt denies pain. Va os: 20/20 cl. Anterior segment exam os: tear film: good; conj: white; cornea: clear; anterior chamber: deep and quiet; iris: wnl; lens: clear; anterior vitreous: normal. Impression: open angle with borderline findings, low-risk. Bilateral-stable. Discussion: glaucoma suspect ¿ cupping. Pt is a glaucoma suspect secondary to increased cup to disc ratio and/or asymmetric cups. Pt was instructed that there was an increased risk of glaucoma and permanent vision loss. Increased risk requires continued observation. Return visit 1 year. On (b)(6) 2018 a call was placed to the pts ecp and a representative reported the pt was overdue for an exam when seen for corneal ulcer follow-up. Representative reported there is no information in the pts record indicating the pt was released to wear contact lenses. No additional medical information was provided. On (b)(6) 2018 a call was placed to the pt who reported the ecp advised the pt could return to contact lens wear on the last visit. The pt will return for a contact lens exam in (b)(6) 2019. No additional medical information has been received. The suspect os contact lens was discarded by the pt. 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 b00pmq0 was produced under normal conditions. If any further relevant information is received, a supplemental report will be filed.
 
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Brand NameACUVUE OASYS 1-DAY FOR ASTIGMATISM WITH HYDRALUXE TECHNOLOGY
Type of DeviceLENSES, SOFT CONTACT
Manufacturer (Section D)
JOHNSON & JOHNSON VISION CARE, INC. ¿ US
7500 centurion parkway
jacksonville FL
Manufacturer Contact
rose harrell
7500 centurion parkway
jacksonville, FL 32256
9044433364
MDR Report Key8206855
MDR Text Key131767873
Report Number1057985-2018-00148
Device Sequence Number1
Product Code LPL
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K042275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial
Report Date 12/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberTAS
Device Lot NumberB00PMQ0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/31/2018 Patient Sequence Number: 1
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