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 Bacterial Infection (1735); Corneal Ulcer (1796); Vitreous Floaters (1866); Nausea (1970); Visual Impairment (2138); Visual Disturbances (2140); Excessive Tear Production (2235); Eye Pain (4467)

Event Date 09/07/2022

Event Type  Injury  

Manufacturer Narrative

Suspect product discarded.

Event Description

On 11oct2022, a johnson and johnson account manager was advised by a optical manager that a patient (pt) had a ¿severe eye infection¿ and was admitted to the hospital.The pt was wearing an acuvue oasys brand contact lens (cl) that split in the eye (affected eye was not provided).On 21oct2022, received additional information from the pt.The pt reported the od was ¿damaged.¿ on (b)(6) 2022, the pt reported a ¿pinch¿ when removing the suspect od cl.The pt reported wearing the suspect od for about 1.5 hours, felt uncomfortable, so the cl was removed, and a ¿tear¿ was noted in the center of the cl.Later the next day (b)(6) 2022, an od cl was inserted and worn for about 3 hours.The pt reported ¿agony¿ when the suspect od cl was removed.The pt presented to the hospital about 4:00 am due to od eye pain.The pt reported the eye was ¿anaesthetised¿ before the eye exam was possible.The doctor in the emergency hospital advised a ¿corneal abruption, cornea had been ablated.¿ there was a ¿huge wound to the od.¿ the pt reported a ¿small tear to the cornea from ¿damaged lens¿ that led to a huge would to cornea, 5.9 x 3.9 mm, the pt recalls.The pt was given medications (medication names not provided) and was discharged home the following afternoon.The pt was admitted to the hospital on (b)(6) 2022 for 9 days with pseudomonas and serretia od.The pt reported there are ulcers in the od and was treated every hour initially, then every 2 hours.The pt was discharged home from the hospital with ¿many medications¿ (name of medication not provided).The pt reported return visits for pain management, follow-up recheck eye visits and procedures.The pt reported the recovery is slow and the od is improving but reports ¿damaged vision¿ with ¿black flashes.¿ the od wound is reducing and the pt wears black glasses to help with photophobia.The pt will no longer be able to wear cl.The pt reported the next follow-up visit is scheduled on (b)(6) 2022.The pt reported daily cl wear and used bausch and lomb renu solution.On 23oct2022 additional medical information was provided by email from the pt through the account.The email contained 3 attachments: 1.Slit lamp photo of eye; 2.Photo of eye; 3.Photo of medical records for (b)(6) 2022 and (b)(6) 2022.Date of visit: va od: 6/60, best corrected; (6/24 pinhole).The pt was seen at the clinic with complaints of pain since wednesday; vision: unchanged; photosensitive: feels travel type nausea.Imp: clak od - ulcer better (reduced size a little) plan: od drops only: stop ofloxacin 0.3% 6x/day; sta.Rt levofloxacin 0.5% pf 6x/day; stop gen 1.5% 6x/day; cef 5% 4x/day; pheny 2.5% minims 3x/day; cyclo 1% minims 3x/day; po ciprofloxacin 750 mg bid for 7 days, then stop; reduce prednisone 0.5% minims 1x/day; hylonight at night od; start clinitas 0.4% pf 4-6x/day; start po doxxycycline 100mg 2x/day.Separate page, cut off with no date: discharge medications: ciprofloxacin 750mg bid for 7 days; cyclopentolate eye drops (minims) 1% od tid; gentamicin eye drops 1.5% od 6x/day; ofloxacin 0.3% eye drops od 6x/day, phenylephrine 2.5% eye drops pf minims od tid.Date of visit: (b)(6) 2022: visual acuity: od 6/24, best corrected.Management plan/comments: previous ocular hx: ¿eed 9/9/22: od clak¿ admitted: pseudomonas and serratia growth; discharged (b)(6) 2022.Pt presented eed: (b)(6) 2022: worsening pain; felt to be improving and discharged.Clinic visit: (b)(6) 2022: ongoing pain but no worsening vision; felt to be improving objectively.Currently: ongoing pain, worse in morning - improving in intensity; epiphora, photosensitivity; feels.Vision improving; noting black spots - not previously noticed in od.Current eye treatment: levofloxacin 0.5% pf 6/day od; cefuroxime 5% qds; phenylephrine 2.5% tds; cyclopentolate 1% tds; predsol 0.5% od; hylonight od; clinitas pf 4-6/day od; po doxycycline 100 bd.Outcome: levofloxacin 4/day od; pred 0.5% minims 2/day; clinitas 0.4% pf 2 hourly; hylonight at night od; table doxycycline 100mg 2/day.Pt to return in 4 weeks.No additional medical 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 l005crh was produced under normal conditions.The od suspect cl was discarded.No additional evaluation can be conducted.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: 15738499
• MDR Text Key: 303141390
• Report Number: 1057985-2022-00088
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• 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: L005CRH
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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): Required Intervention; Hospitalization; Other
• Patient Sex: Female