MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US 1-DAY ACUVUE MOIST; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1DM

Device Problem No Apparent Adverse Event (3189)

Patient Problem Pain (1994)

Event Date 10/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On 27oct2017, our affiliate in (b)(4) was contacted by a johnson and johnson sales representative who reported: on (b)(6) 2017, a patient (pt) experienced pain after inserting a 1 day acuvue moist contact lens.The pt removed the lens and noticed ¿something like staple whose size was 2-3 mm got stuck in the eye.¿ pt presented to an eye care provider (ecp) on the same day and the ¿staple-like thing¿ was removed from the eye under local anesthesia.The ecp reported he/she ¿does not consider the event to be cl related¿ and ¿the staple like thing came into the eye when the pt was inserting the lens.¿ on 08nov2017, the j and j sales representative sent an email advising the ecp was contacted and additional information was provided: ecp reported ¿something like staple got stuck in pt¿s eye.¿ the ecp applied oxybuprocaine hydrochloride ophthalmic solution to remove the object.The treating ecp provided a photo image of the pt¿s eye prior to removing the object.The pt was instructed to discontinue cl wear for a while without instruction to return for follow up.Levofloxacin ophthalmic solution and gatifloxacin ophthalmic solution were prescribed.The pt did not return to the clinic after the ¿surgery.¿ the object in question was discarded upon removal; the product lot number is not available.It is not known which eye was affected.No additional information has been provided.No additional information is expected to be received.This event is being reported as a worst-case event.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.

• Brand Name: 1-DAY ACUVUE MOIST
• Type of Device: LENSES, SOFT CONTACT, 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: 7054352
• MDR Text Key: 92805402
• Report Number: 1057985-2017-00135
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2017

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 Catalogue Number: 1DM
• Device Lot Number: UNK-1DM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 40