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

Catalog Number CYP

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

Patient Problems Irritation (1941); Keratitis (1944); Red Eye(s) (2038); Swelling (2091); Excessive Tear Production (2235)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

On (b)(6) 2019 a patient (pt) from (b)(6) called to report os irritation, redness, tearing and swelling on (b)(6) 2019 the 1st day while wearing an acuvue® oasys® for astigmatism brand contact lens.On (b)(6) 2019 the pt went to an urgent care and the eye care provider (ecp) and diagnosed a ¿corneal lesion¿ and prescribed lubricating drops five times daily and vigamox every 4 hours until the return visit.On 25 sept 2019 the pt returned for a follow- up ecp visit and was advised to discontinue the vigamox and continue the lubricating drops.The pt reported the ecp advised to ¿avoid contact lens wear¿.The pt has not returned to contact lens wear and reports is only wearing glasses.The pt reported contact lens daily wear with a replacement schedule of 15-20 days.The pt used opti-free to disinfect the lenses.On (b)(6) 2019 a call was placed to the pts treating ecp and a representative reported the pt was diagnosed with keratitis.No additional medical information was provided.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 b00nwvm was produced under normal conditions.The suspect os contact lens was discarded.No evaluation can be conducted.If any further relevant information is received, a supplemental report will be filed.

• 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: 9203938
• MDR Text Key: 175067488
• Report Number: 1057985-2019-00097
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: BR
• 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
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: CYP
• Device Lot Number: B00NWVM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2017
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 32 YR