MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE - 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 Ulcer (1796); Eye Injury (1845); Red Eye(s) (2038); Corneal Infiltrates (2231)

Event Date 09/02/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : refused to return suspect cl.

Event Description

On 25sep2023, a family member reported a patient (pt) in spain "had a problem" with acuvue brand contact lenses (cls).The date of event, details of the event, and brand of lenses were not provided.Attempts were made to obtain additional information from the family member on 26sep2023 and 27sep2023 with no success.On 28sep2023, the family member called to provide additional information.The pt has been a cl user for 6 months and sometimes exceeds the time of wear of the lenses.The pt experienced irritation and redness, mostly on the bottom of the eye, in the right eye (od) on the 3rd day of wear.The pt has been to several ophthalmologists and doctors because of this concern.The pt does not sleep or bathe in cls.The pt did not come into contact with any other water source and was not ill or have any infection while wearing the cls.The pt first visited an eye care professional (ecp) on 02sep2023 and was diagnosed with od conjunctival hyperemia and corneal abscess with epithelial defect (culture "all ok").The pt's family member could not provide details of the medication prescribed at the time of the call but will send via email.A follow-up visit is scheduled with the ecp on (b)(6) 2023.The od is now "a lot better." on 04oct2023, the pt's family member provided medical documents by email.On 04oct2023, translation of the medical documents was provided.Visit dated: (b)(6) 2023.Pt comes for evaluation without correction and intense photophobia.Slit lamp exam: od mild ciliary hyperemia-mod, transparent cornea, nasal paracentral epithelial defect with 1x1 mm anterior stromal abscess, no infiltrate, anterior chamber good depth no tyndall or hypopyon, reactive phakic pupil.Intraocular pressure good symmetrical tone.Normal applied ocular fundus.Clinical judgment: contact lens abscess action plan: ciprofloxacin eye drops 2 times a day until review.Cycloplegic eyedrop twice daily (bid).Abundant artificial tears.Follow-up in 48 hours.External consult ophthalmology.If worsening, go for urgent care.Visit dated (b)(6) 2023 slit lamp exam: od stable hyperemia, nasal paracentral epithelial defect 0.5x0.5 on persistent abscess of 1x1 mm, no tyndall, anterior chamber or other findings.Intraocular pressure good tone.Ocular fundus without alterations.Clinical judgment: contact lens abscess action plan: ceftazidime and vancomycin eye drops alternate every 1 hour with a night's rest; cycloplegic eyedrops "2 bid," and artificial tears.Samples are taken for culture.Follow-up on 06sep2023.Visit dated (b)(6) 2023 slit lamp exam: defect with underlying abscess <0.5x0.5.Rest well, no local infiltrate or intraocular involvement.Intraocular pressure 16.Ocular fundus ok.Follow-up 09sep2023 clinical judgment: contact lens abscess visit dated (b)(6) 2023 slit lamp exam: od residual punctate epithelial defect, no underlying abscess appears, slight local infiltrate approximately 0.5x0.5 cornea rest normal.Intraocular pressure good symmetrical tone.Evolution and clinical course: anterior eye abscess in od "of 1 week of evolution." treatment: fortified eye drops every 2 hours alternating.Cyclopegic eye drops 2 times a day.Rest at night.Contact lens abscess.Action plan: ciprofloxacin every 6 hours, gentamicin ointment every 8 hours, "fluorometolona" every 8 hours, "eyestill synfo" artificial tears 5 times a day.Review in 1 week: 19sep2023.On 04oct2023, the family member provided the lot number, confirming the suspect product is an acuvue® oasys® brand cl.The pt will provide another medical report via email.On 11oct2023, the family member provided additional information.The pt's eye is completely healed, there are no additional medical appointments scheduled and the pt is receiving no further treatment.No additional information has been received.A lot history review was performed and revealed the following: the batch records did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot number l005jzd was produced under normal conditions.The od suspect cls were requested but return was refused.No additional evaluation can be performed.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 - IRELAND; 1 technological park plassey; limerick LK130 01; EI LK13001
• Manufacturer Contact: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256 ; 9047429918
• MDR Report Key: 17949350
• MDR Text Key: 325838527
• Report Number: 1057985-2023-00075
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• 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: L005JZD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention