MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE ¿ USA 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); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Nicole carnt, jeremy hoffman, seema verma, cherry radford, darwin c.Minassian and john k.G.Dart: acanthamoeba keratitis: confirmation of a current (b)(6) outbreak and a prospective case control study identifying contributing risk factors.(b)(4).

Event Description

On 23 march 2018, an email was received from an eye care professional (ecp).The ecp is the author of a prospective study, conducted in the (b)(6), that has been submitted for publication in 2018.The email contained an attached summary data spreadsheet containing the medical information for subjects involved in the prospective acanthamoeba keratitis study.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) 2013 with severe glare, severe pain, slight redness, and swelling os.The pt was diagnosed with acanthamoeba keratitis os.The pt reported wearing an acuvue trueye brand contact lens (it is unknown if the pt was wearing nara a or nara b brand).Pt reports participating in water sports with no goggles and showered in lenses.The pt was admitted for 3 days for intensive treatment.Treatment also included antiemoebics for 15 months and doxyclyclene.Va: 6/9 (20/30).Pt did not return for follow-up.No additional information is expected to be received.The lot number of the suspect product is unknown.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 ¿ USA; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7434072
• MDR Text Key: 105641173
• Report Number: 1057985-2018-00052
• Device Sequence Number: 1
• Product Code: LPL
• 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

• 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
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 47