MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US UNK-SOFT CONTACT LENSES

Catalog Number UNK-SOFT CONTACT LENSES

Device Problem No Apparent Adverse Event (3189)

Patient Problems Acanthameba Keratitis (1945); Pain (1994); Red Eye(s) (2038)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On 23 march 2018, an email was received from an eye care professional (ecp).The email contained an attached summary data spreadsheet containing the medical information for subjects involved in the study of acanthamoeba keratitis conducted in the uk.The information received from the ecp included only those study subjects who reported wearing acuvue brand products at the time of the adverse event.All the study subjects were initially examined and diagnosed with acanthamoeba keratitis during 2011-2014.The patient (pt), study id (b)(6), presented to the hospital on (b)(6) 2014 with severe photophobia, redness and pain.The pt was diagnosed with acanthamoeba keratitis.The pt reported wearing acuvue advance brand or acuvue oasys brand contact lenses, it was unknown which acuvue brand the pt was wearing at the time of the event.The pt presented to the hospital on (b)(6) 2014 with severe photophobia, redness and pain od.Pt also reported sleeping in the lenses 6 nights/year, 1 night in a row, showered in the lenses and did not dry hands after washing.Pt also reported using synergi solution.Pt was treated with antiamoebics for 4 months.Va: 6/6 (20/20).No additional information is expected to be received.It is unknown which acuvue brand was the suspect product.The suspect product is not available for return for evaluation.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: UNK-SOFT CONTACT LENSES
• Type of Device: UNK-SOFT CONTACT LENSES
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256
• MDR Report Key: 7436565
• MDR Text Key: 105723552
• Report Number: 1057985-2018-00060
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK-SOFT CONTACT LENSES
• Device Lot Number: UNK-UNK-SOFT CONTACT LENSES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: SYNERGI SOLUTION
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 25