MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE 2; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number AV2

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

Patient Problems Keratitis (1944); Red Eye(s) (2038); Burning Sensation (2146); Discomfort (2330)

Event Date 05/19/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 21may2019 a patient (pt) in (b)(6) called to report a diagnosis of keratitis on the right eye (od) while wearing an acuvue 2 brand contact lens.The pt reported discomfort, like a ¿scratching sensation¿ with 3 lenses on (b)(6) 2019.The pt continued to wear 1 of the suspect lenses on the od for 2 days and experienced a burning sensation, redness and ¿scratchy sensation¿.The od remained red after removing the suspect lens.The pt went to the er on (b)(6) 2019 and was diagnosed with keratitis od.The pt was prescribed zymar 1 drop every 2 hours for 10 days and lacrifilm 1 drop every 4 hours for 10 days.Contact lens wear was suspended for 10 days.The pt reported a return visit to the eye care provider (ecp) on (b)(6) 2019.Pt reports daily wear with a weekly replacement schedule.On (b)(6) 2019 additional information was received from the pt.Pt had a follow-up appointment with the ecp on (b)(6) 2019 and reported the od cornea is now ok.The pt was advised to continue zymar 1 drop every 2 hours and to return to the ecp after the treatment is completed.On (b)(6) 2019 a call was placed to the pt and additional information was provided.The pt will send a copy of the prescription.Pt advised on the follow-up appointment on (b)(6) 2019, the zymar was changed to every 4 hours for the remainder of the 10 days.The ecp advised there is great improvement of od and a return appointment was not required.The ecp advised the pt it was ok to return to contact lens wear after the treatment was completed.If symptoms return, contact lens wear should be discontinued.On (b)(6) 2019 additional information was received from the pt.An ecp note dated (b)(6) 2019, icd code h16.8 (other keratitis), received from pt, ¿use of gelatinous contact lens.Slept with contact lens.Inferior keratitis.Return on (b)(6) 2019".Copy of prescription from the ecp (date of prescription is cut off): 1 drop every 2 hours for 10 days; lacrifilm 1 drop every 4 hours for 10 days.No additional medical information was provided.The suspect lens was requested for return, but it has not yet been 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 b00qwm1 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 09jul2019 the patient (pt) called to report successfully wearing acuvue oasys brand contact lenses without further issue.On 11jul2019 the pt sent an email to advise that no medical report was received when the pt went to the public hospital.No additional medical information was provided.Four worn lenses were received in a plastic container for lot # b00qwm1.The worn lens # 1 was torn in half and was unable to be measured.The worn lens # 2 had an edge tear to the middle of the lens and was unable to be measured.The worn lenses # 3 and # 4 met company standards for base curve, center thickness, and diameter.A microscopic visual inspection revealed edge chips for lens # 3 and lens # 4.This product was returned opened and it is not known what external influences may have contributed to the evaluation results.If any further relevant information is received, a supplemental report will be filed.Section h ¿ 6: code 10 ¿ testing of actual/suspected device.

• Brand Name: ACUVUE 2
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• MDR Report Key: 8684561
• MDR Text Key: 147512089
• Report Number: 1057985-2019-00053
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2023
• Device Catalogue Number: AV2
• Device Lot Number: B00QWM1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Date Manufacturer Received: 07/09/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR