MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. - US 1-DAY ACUVUE® MOIST® FOR ASTIGMATISM LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1MA

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

Patient Problems Corneal Scar (1793); Dry Eye(s) (1814); Blurred Vision (2137); Eye Pain (4467)

Event Date 11/01/2021

Event Type  Injury  

Event Description

On 07dec2021 a reporting eye care provider (ecp) in (b)(6) called to report a patient (pt) was diagnosed with ¿severe cornea scarring due to dry eyes¿ while wearing the 1-day acuvue® moist brand contact lenses (cls) for astigmatism. The event occurred on (b)(6)2021 and both eyes were affected. He ecp reported the pt tried lenses from multiple cls boxes and experienced discomfort, pain and blurry vision with the suspect lenses. The pt was prescribed unknown eye drops and advised to discontinue cls wear. The eyes are still ¿blurry and unwell,¿ and the pt continues to experience blurry vision while wearing spectacles. The ecp reported that the pts prescription hasn¿t changed. The ecp will contact the pt again to request the medical certificate and the name of the prescribed eye drops after the pts eyes are feeling better. On 08dec2021 the reporting ecp advised that a call will be placed to the pt on 10dec2021 to request the additional medical information. On 10dec2021 the pts reporting ecp attempted to contact the pt to obtain additional medical information. The pt is currently unavailable and is currently hospitalized for medical issues unrelated to contact lenses or both eyes. The ecp reported the pt tried 1-2 lenses from multiple cls boxes for the 1-day acuvue® moist brand contact lenses for astigmatism. The suspect lot #¿s are reported as j002bw2 and 6447200101 for the pts os. 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 j002bw2 was produced under normal conditions. 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 6447200101 was produced under normal conditions. This report is for the pts os event. The report for the pts od event will be submitted in a separate report. The suspect os cls was requested for return for evaluation, but they have not yet been received. If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

Product requested but not yet received.

Event Description

On 07dec2021 a reporting eye care provider (ecp) in (b)(6) called to report a patient (pt) was diagnosed with ¿severe cornea scarring due to dry eyes¿ while wearing the 1-day acuvue® moist brand contact lenses (cls) for astigmatism. The event occurred on (b)(6)2021 and both eyes were affected. He ecp reported the pt tried lenses from multiple cls boxes and experienced discomfort, pain and blurry vision with the suspect lenses. The pt was prescribed unknown eye drops and advised to discontinue cls wear. The eyes are still ¿blurry and unwell,¿ and the pt continues to experience blurry vision while wearing spectacles. The ecp reported that the pts prescription hasn¿t changed. The ecp will contact the pt again to request the medical certificate and the name of the prescribed eye drops after the pts eyes are feeling better. On 08dec2021 the reporting ecp advised that a call will be placed to the pt on 10dec2021 to request the additional medical information. On 10dec2021 the pts reporting ecp attempted to contact the pt to obtain additional medical information. The pt is currently unavailable and is currently hospitalized for medical issues unrelated to contact lenses or both eyes. The ecp reported the pt tried 1-2 lenses from multiple cls boxes for the 1-day acuvue® moist brand contact lenses for astigmatism. The suspect lot #¿s are reported as j002bw2 and 6447200101 for the pts os. 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 j002bw2 was produced under normal conditions. 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 6447200101 was produced under normal conditions. This report is for the pts os event. The report for the pts od event will be submitted in a separate report. The suspect os cls was requested for return for evaluation, but they have not yet been received. If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

Product requested but not yet received.

• Brand Name: 1-DAY ACUVUE® MOIST® FOR ASTIGMATISM
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. - US; 7500 centurion parkway; jacksonville FL 32256
• Manufacturer Contact: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433835
• MDR Report Key: 13079193
• MDR Text Key: 285545629
• Report Number: 1057985-2021-00181
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 1MA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/23/2021 Patient Sequence Number: 1