MAUDE Adverse Event Report: JOHNSON AND JOHNSON VISION - US ACUVUE OASYS BRAND CONTACT LENSES; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number UNK-SOFT CONTACT LENSES

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bacterial Infection (1735); Conjunctivitis (1784); Corneal Ulcer (1796); Keratitis (1944); Loss of Vision (2139); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On 03oct2016 a letter was received from a patient¿s (pt) family member who reported that ¿in regard the pts injury and developed an bad infection which is called ¿pseudomo keratitis¿.The pts family member reported that the eye care provider (ecp) ¿said it was from the contact and these were a different kind so, the bacteria was so aggressive it was beginning to eat a hole in the cornea.¿ ¿they did everything to save the pts eye, which was a big ulcer and after four doctors came to the same conclusion, they could not save it.So a few days later they took it out.¿ on 17oct2016 a call was placed to the pts family member.No additional information was obtained.The product, lot number, and product availability are unknown.The date of the event is also unknown.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.

Manufacturer Narrative

On 31jul2017 the patient¿s (pt) family member called with the additional medical information: the pts family member reported a lens ¿cut the eye which caused the pt to lose the eye¿.The family member reported the pt began to experience ¿pink eye¿ like symptoms in (b)(6) 2016.The pts family member handed the telephone to the pt who also provided additional medical information.The pt reported wearing the acuvue oasys brand contact lenses for over twenty years without issue.The pt reported in (b)(6) 2016 he/she began to experience discomfort in the left eye while wearing the suspect lens.The suspect lens was removed that evening and was placed in a lens case with solution (name of solution was unknown).The pt reported the next morning the suspect lens was again placed in the left eye.The pt reported the suspect lens ¿didn¿t feel right, but wore it all day at work¿.The pt removed the left eye suspect lens after work and placed it in the lens container.The following am the noted left eye discomfort, ¿pink eye¿ symptoms and again inserted the suspect left eye lens and went to an eye care provider (ecp) for an eye check.The pt reported the ecp put a yellow drop in the left eye and advised the pt the suspect lens was torn in two places and he/she had a ¿scratch in the center of the cornea¿.The pt was prescribed an antibiotic eye drop (name of the eye drop is unknown).Pt could not recall how many times per day or how long the drop was prescribed.The pt reported the antibiotic eye drops were changed many times during the treatment (names and frequency of the drops were unknown).Pt reported the left eye did not get better with treatment.The pt reported he/she went back to the ecp who advised the pt he/she had a ¿bacterial eye infection unlike any they¿d seen¿.The pt reported the bacterial infection would not heal, so the left eye was removed in (b)(6) 2016.The pt reported he/she was doing well now, but only has the od vision and is unable to work full-time due to the eyesight.The pt reported he/she had been wearing the suspect lens for two to three weeks prior to experiencing the left eye event.The pt reported he/she does not sleep in the lenses.No additional information was provided.The suspect lens was discarded.Additional information has been requested.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 b00kwbt was produced under normal conditions.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.(b)(4).

Manufacturer Narrative

On 24aug2017 a call was placed to the patient¿s (pt) family member who provided additional information: the pts family member provided the contact information for the facilities the pt received treatment.He/she also reported the pt first visited an emergency room (er) and was advised the pt had a torn lens on the os.The pt was given eye drops (medication name was not provided), but the left eye did not get better so the pt returned to the er.The pt was transported by ambulance to the hospital.The pt received ¿shots in the eye and antibiotics¿.The pt was seen in the ophthalmology clinic for over a month and the treating ophthalmologist was the eye care provider (ecp) who removed the pts left eye.The pts family member reported he/she had some copies of some medical paperwork and could mail the information for review.The pts family member reported the pt may be willing to release the medical information.No additional medical information has been received.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: ACUVUE OASYS BRAND CONTACT LENSES
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON AND JOHNSON VISION - US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 6058261
• MDR Text Key: 58453272
• Report Number: 1033553-2016-00127
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2020
• Device Catalogue Number: UNK-SOFT CONTACT LENSES
• Device Lot Number: B00KWBT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention