MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE VITA; SOFT CONTACT LENS, DAILY WEAR

Catalog Number ATL

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

Patient Problems Corneal Perforation (1792); Foreign Body Sensation in Eye (1869); Blurred Vision (2137)

Event Date 07/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter¿s phone number: (b)(6).

Event Description

On (b)(6) 2020, an eye care provider (ecp) in (b)(6) reported a patient (pt) experienced ¿corneal damaged¿ after wearing an acuvue® vita¿ brand contact lens.No further information was provided.On 31jul2020, additional information was received from the pt: the pt reported experiencing blurry vision in the right eye (od) on the third day of wearing the cl ((b)(6) 2020).The pt experienced foreign body sensation upon removal of the contact lens.The pt visited the doctor and was diagnosed with ¿corneal rupture.¿ the pt was prescribed: recombinant human epidermal growth factor eye drops to use 1-2 drops, 6-8 times a day; compound tropicamide eye drops to use 1 drop every 5 minutes, 4 times and then discontinue; tobramycin eye drop to use 1-2 drops, 2-3 times a day; ofloxacin eye ointment to use 2-3 times a day.The pt returned to the doctor for a follow-up on (b)(6) 2020 and was advised to continue using recombinant human epidermal growth factor eye drops 6-8 times a day but can reduce the amount of other eye drops (unspecified).No further information was provided.Multiple attempts have been made to contact the pt to obtain additional information.No further information has been received.The suspect od contact lens was discarded.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 b00v442 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE VITA
• Type of Device: SOFT CONTACT LENS, DAILY 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: 10431573
• MDR Text Key: 210230079
• Report Number: 1057985-2020-00041
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K160212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: ATL
• Device Lot Number: B00V442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention