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

Catalog Number CYP

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796)

Event Date 11/15/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Pt called on (b)(6) 2017 to a report a left eye bacterial corneal ulcer in 2008 while wearing an unknown acuvue brand contact lens.Pt was advised the ulcer was outside the cornea and pt had a scar from the event.The pt was unable to provide any treatment prescribed.Pt reported a monthly replacement schedule and did not sleep in the lenses.Pt was unable to recall the name of the solution used to disinfect and store the lenses.On 27dec2017 a call was placed to the pts treating eye care provider¿s (ecp) office and additional medical information was requested.On 03jan2018 a call was placed to the pts treating ecp and additional information was provided: the ecp reported the pt was seen in 2008 for a routine exam.On (b)(6) 2010 the pt was diagnosed with a small left eye bacterial central corneal ulcer while wearing the acuvue oasys for astigmatism brand contact lenses.Pt was prescribed vancomycin and garamycin drops every two hours.Ecp reported the pt was seen for follow-up on (b)(6) 2017, (b)(6) 2010.The ecp reported the left eye had improved on the (b)(6) 2010 visit.The pt has not been back to the office since (b)(6) 2010.Ecp reported the pt had a 2004 left eye corneal ulcer with scarring while wearing a non acuvue brand contact lens.No additional information was provided, no additional medical information is expected.The lot number is unknown and the suspect lens is not available.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.

Manufacturer Narrative

During a file review on 08feb2018 it was noted there was a date error in the event summary.Ecp reported the pt was seen for follow-up on (b)(6) 2017.The date that was documented as ¿(b)(6) 2017¿ should be (b)(6) 2010.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: ACUVUE OASYS FOR ASTIGMATISM
• 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: 7201963
• MDR Text Key: 97605376
• Report Number: 1057985-2018-00007
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CYP
• Device Lot Number: UNK-CYP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2018
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 22 YR