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

Catalog Number PH

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

Patient Problems Corneal Edema (1791); Burning Sensation (2146); Discomfort (2330)

Event Date 10/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 019, an email was received from a 3rd party company in (b)(6) reporting a patient¿s (pt) diagnosis of ¿erosiones corneae superficiales¿ while wearing an acuvue® oasys® brand contact lens (cl).A medical report dated 02oct2019 was provided: ¿diagnosis: erosiones corneae superficiales o.Dex; anamnesis: approximately 3 hours ago she inserted soft contact lenses which she uses from time to time.She opened completely new lenses, but the type which she didn't use before, and she inserted it only in the right eye and immediately felt burning and discomfort; status: vod:cc = 0,8; vos: cc = 0,9 (with her own glasses); bm o.Dex: tiny surface erosion of the epithelium difuse along the entire cornea with some corneal edema; conclusion: during 3-5 days apply the therapy and control if necessary; therapy: sol.Ciloxan 5x + ung.Bepanthen 2x (for eyes).¿ on 22oct2019, the optics store was contacted, and additional information was received.The pt returned to cl wear after the event and is wearing a previous brand of cls.No further information was provided.No additional information has been received.The suspect right eye (od) cl has been requested for return, but not yet received.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 l003zmj was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE OASYS
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 9252295
• MDR Text Key: 180441502
• Report Number: 9617710-2019-00041
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: HR
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PH
• Device Lot Number: L003ZMJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2019
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 18 YR