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

Catalog Number ACU

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

Patient Problems Bacterial Infection (1735); Eye Injury (1845); Keratitis (1944); Corneal Infiltrates (2231)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2020 during a literature review search in (b)(6), a journal ¿the japan contact lens society, 2020, volume 61, no.4, pp.123 to 131¿, study titled, ¿contact lens-related microbial keratitis in gelatinous drop-like corneal dystrophy¿ indicated the study subjects involved were wearing acuvue® brand contact lenses.All the study subjects were initially examined and diagnosed with microbial keratitis during 2002 to 2018.During the sixteen-year study period, several study subjects experienced multiple events.The patient (pt) (study id 5, 1st event), was reported wearing the acuvue® brand contact lens with an unknown lot number.The date of the event was not provided.The study indicated the pt was also diagnosed with ¿corneal epithelial defect¿ and corneal infiltrates (affected eye unknown).It is unknown if a corneal scraping was performed.No contact lens culture was submitted.The pt was treated with a steroid installation of betamethasone.The pt was also treated with ofloxacin eye drops.The betamethasone eye drops were discontinued.Additional treatment included: lamellar keratoplasty (¿lkp3¿), brown (¿brown1¿), superficial corneal resection (¿sk1¿).No additional medical information was provided.No additional information is expected.The suspect product is not available.The lot number is unknown.No additional investigation can be performed.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE
• Type of Device: LENSES, SOFT CONTACT, EXTENDED 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: 10869479
• MDR Text Key: 218731226
• Report Number: 1057985-2020-00067
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• 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: 11/19/2020

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: ACU
• Device Lot Number: UNK-ACU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 23