MAUDE Adverse Event Report: JOHNSON AND JOHNSON VISION CARE INC ACUVUE OASYS FOR ASTIGMATISM BRAND; SOFT CONTACT LENS

Lot Number B00HVCQ

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Eye Injury (1845)

Event Date 07/01/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, our affiliate received a phone call from a pt's relative to report that in (b)(6) 2014 the pt purchased a new pack of acuvue oasys for astigmatism lenses.It is reported that "after a day of wearing the lens, the pt's relative claimed that the next day, the pt could not open one of his/her eyes.The relative claimed that they had to run to the emergency, the eye care professional (ecp) was only able to open the pt's eye with a special tool and take off the lens.After this, the relative claimed that they realized a white-transparent-undertoned layer on the pt's eye.The pt's eye could not recover due to different treatments since the last 3 months, medication, and eye drops.The relative named one of the eye drops they used as "broken".The relative claimed that the ecp could not define the cause of this problem, tried different medications, and eye drops, and now ecp decided to operate on the eye to make "a patch" on the cornea on (b)(6) 2014.".

Manufacturer Narrative

Device labeling: single use or reuse."if this patching does not work, the ecp advised cornea transplant as only solution left." multiple unsuccessful attempts have been made to obtain additional info from the pt's treating ecp.The product was requested for return for eval, but it has not yet been received.A lot history review was performed and revealed the batch did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.If additional info is received, will report within 30 days of receipt.Serious reportable event trends are reviewed quarterly in executive mgmt review meetings.If additional info is received, will report within 30 days of receipt.Serious reportable event trends are reviewed quarterly in executive management review meetings.

Manufacturer Narrative

Product evaluation: three sealed blisters were received.The parameters of the lenses were measured and a visual inspection was performed.The lenses met company standards for base curve, center thickness, and diameter.No visual attributes were observed.The solution was also tested; the ph was in specification; there was not enough solution to measure conductivity.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.(b)(4).

• Brand Name: ACUVUE OASYS FOR ASTIGMATISM BRAND
• Type of Device: SOFT CONTACT LENS
• Manufacturer (Section D): JOHNSON AND JOHNSON VISION CARE INC; jacksonville FL
• Manufacturer Contact: rose harrell ; po box 10157; jacksonville, FL 32247 ; 9044433647
• MDR Report Key: 4316987
• MDR Text Key: 18270145
• Report Number: 1033553-2014-00115
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 12/04/2014

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 Expiration Date: 07/01/2019
• Device Lot Number: B00HVCQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2015
• Initial Date Manufacturer Received: 01/23/2015
• Initial Date FDA Received: 12/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR