MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE OASYS; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number PH

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

Patient Problems Bacterial Infection (1735); Conjunctivitis (1784); Irritation (1941); Pain (1994); Red Eye(s) (2038); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2020 a patient (pt) called to report od redness, irritation and a ¿bump¿ on the lower eye lid about a month ago while wearing the acuvue oasys brand contact lenses.The pt went to the general practitioner (gp) who prescribed an oral antibiotic (not provided) and gentamycin eye drops, but no specific diagnosis was provided at that time.The pt reported the od became red after using the gentamycin eye drops, so the pt went to the eye care provider (ecp).The ecp advised the pt to stop using the eye drops and prescribed a steroid eye drop qid (name of eye drop not provided) and no contact lens wear for about a week.On 19 feb 2020 a call was placed to the pts prescribing ecp¿s office and a representative provided the additional medical information: the pt came in on (b)(6) 2019 with complaints of irritation and pain.The pt was diagnosed with bacterial conjunctivitis and hyperemia and prescribed ofloxacin.The representative was unable to provide further details.On 20 feb 2020 a call was placed to the pts prescribing ecp¿s office and additional information was provided: a representative reported the pt was treated by a gp 10 days prior to presenting to the ecp¿s office with complaints of pain and irritation when blinking.The pt was prescribed oral amoxicillin and gentamycin drops.The pt reported redness started only after starting the gentamycin.The pt returned to the gp after 4 days and was prescribed cipro for 3 days and no contact lens wear.The ecp documented possible bacterial conjunctivitis od, likely caused by an allergic reaction to the gentamycin.On exam, the ecp saw no staining or infiltrates.The representative reported the pt was overdue for an eye exam and the last eye exam was in (b)(6) 2019.The representative will provide the pts medical records for evaluation.On 20 feb 2020 the pts medical records were received from the ecp¿s office: date of visit: (b)(6) 2019.Chief complaint: pt c/o od has been red, irritated, and pain when blinking.Getting worse over past day or so.Started about 10 days ago.Saw md last week and was given amoxicillin 500mg bid and gentamycin gtts q4h for 4 days then went back and was switched to ciprofloxacin q2h, using that for 3 days.Has not worn cls.Exam od: vision corrected: dist w/ glasses: 20/20 -2.Od conj/ scl: hyperemia, conj on the lower temporal eyelid margin; bacterial conjunctivitis.Od cornea: epi, stroma, endo, tear film wnl.Od ac: deep and clear w/o cells or flare.Impression: od bacterial conjunctivitis; od hyperemia, conj.Plan: ofloxacin eye drops os (qid) instill in eyes 15 days supply, discontinued on (b)(6) 2019; ofloxacin drops os (four times a day) instill into the left eye 14 days supply, discontinued (b)(6) 2019; bacterial conjunctivitis od; pt says redness of eye really started significantly after started gentamycin gtts.Will use up the amoxil po, use cipro gtts qid and add lotemax qid for one week, rtc prn.Probably element of allergy to the gent is present, no corneal stain or infiltrates.On 25 feb 2020 the representative at the pts ecp¿s office called to clarify the medical records they provided on 20 feb 2020.The pt was only diagnosed with bacterial conjunctivitis od; the os was fine on exam and nothing was prescribed for the os.The event date is 2019.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 b00t1qd was produced under normal conditions.The suspect od contact lens was discarded.No additional investigation can be conducted.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE OASYS
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• 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 Key: 9824148
• MDR Text Key: 196390951
• Report Number: 1057985-2020-00022
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PH
• Device Lot Number: B00T1QD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention