MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US UNK-SOFT CONTACT LENSES

Catalog Number UNK-SOFT CONTACT LENSES

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

Patient Problem Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

Evaluation codes: contact lens; adverse event without identified device or use problem; device not returned; no findings available; no problem detected.

Event Description

On 24nov2020, a social media post submitted by a patient (pt) was discovered.The pt reported ¿guys these contacts literally made me blind.¿ it is unknown which acuvue brand product the pt was wearing at the time of the event.The event date is unknown.Multiple attempts were made to contact the pt for additional medical and product information.On 11dec2020, the pt responded ¿im good¿.No further information was received.On 16dec2020, an additional attempt was made to contact the pt.The pt responded ¿im fine¿.No further information was received.This event is being reported as a worst-case event as the diagnosis, and treatment were unable to be verified.It is unknown if the suspect product is available for return.The lot number is unknown.No further investigation can be conducted at this time.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: UNK-SOFT CONTACT LENSES
• Type of Device: UNK-SOFT CONTACT LENSES
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; +904443364
• MDR Report Key: 11029026
• MDR Text Key: 222099125
• Report Number: 1057985-2020-00074
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK-SOFT CONTACT LENSES
• Device Lot Number: UNK-UNK-SOFT CONTACT LENSES
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other