MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY; LENSES, SOFT CONTACT

Catalog Number TSP

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

Patient Problems Irritation (1941); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

On (b)(6) 2018 a call was received from an eye care provider (ecp) in italy who reported a patient (pt) had a ¿severe allergic reaction¿ to the acuvue oasys®1 day with hydraluxe¿ brand contact lenses within 5 minutes of insertion of the suspect lens.The pts eye (affected eye not provided) was swollen and the pt had an ¿anaphylactic shock and almost went into a coma¿.The pt allegedly went to a local hospital for evaluation.The event occurred 2 weeks ago, (b)(6) 2018.The pt discontinued use of the contact lenses (cl).The reporting ecp provided limited information; the ecp did not examine or treat the pt.On (b)(6) 2018 a johnson and johnson physician contacted the reporting ecp to request additional information.The ecp reported irritation and after the patient removed the suspect lens, there were no further issues.No additional medical information was provided.On (b)(6) 2018 the johnson and johnson physician received additional information from the reporting ecp.The ecp was able to contact the pt.The pt reported that they did not seek medical treatment or receive any medication after the reported event.No additional information is expected to be received.The lot number of the suspect product unknown.The suspect lens was discarded and not available for return for evaluation.This event is being reported as a worst-case event as it was unconfirmed if the pt sought medical intervention or treatment at the time of the event.If any further relevant information is received, a supplemental report will be filed.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY
• Type of Device: LENSES, SOFT CONTACT
• 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: 8081296
• MDR Text Key: 127543015
• Report Number: 1057985-2018-00136
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: K042275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: TSP
• Device Lot Number: UNK-TSP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention