MAUDE Adverse Event Report: JOHNSON AND JOHNSON VISION SURGICAL, INC. COMPLETE EASY-RUB (CHINA); SOLUTIONS

Model Number 08772X

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

Patient Problems Pain (1994); Red Eye(s) (2038); No Code Available (3191)

Event Date 03/23/2018

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, not provided.(b)(6), reporter last name and address not provided.(b)(4).Device evaluation: the solution was not returned to the manufacturing site for investigation.Therefore, an investigation could not be performed and the consumer's reported event could not be confirmed.Manufacturing record review: the records for production process were found to be acceptable, all testing items were completed and met specifications.Historical complaint review: a review of the complaint data revealed that no other complaints were found under this lot number.Labeling review: direction for use of the reported product were reviewed.The directions for use provided instructions, precautions and warnings for the proper use and handling of the product.Based on the results of the investigation, there is no indication of a product malfunction or product quality deficiency.All pertinent information available to johnson and johnson vision surgical, inc.Has been submitted.

Event Description

Report received that a female consumer experienced severe pain, stinging, tearing, swelling, and redness after use of complete easy rub contact lens solution.The consumer went to the hospital and was diagnosed with corneal damage (corneal epithelial injury).She was prescribed 3 different drops and a serum eye gel however, she still feels pain sometimes and she still experiences photophobia and tearing.The consumer provided information that medical intervention was required to treat corneal damage and symptoms.The following medications were prescribed: hypromellose eye drops 0.05 ml ou (both eyes) q.I.D.(4x a day).Sodium hyaluronate eye drops 0.05 ml ou q.I.D.Deproteinised calf serum eye gel 0.05 g ou q.I.D.0.02% fluorometholone eye drops 0.05 ml ou b.I.D.(twice daily).No further information was provided.

Manufacturer Narrative

Corrected data: in the initial report patient code 3191 corneal epithelial injury was inadvertently not included.It has been corrected in this supplemental filing.Device evaluation: the consumer choose not to return the product; therefore, an investigation could not be performed and the customer's reported complaint could not be confirmed.Manufacturing record review: a review of the records was performed.The records for production process were found to be acceptable, all testing items were completed and met specifications.There was no non-conformances related to this complaint.In conclusion, reported lot was deemed acceptable for release.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Based on the results of the investigation, no product deficiency was identified.Alternative report identification number: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• Brand Name: COMPLETE EASY-RUB (CHINA)
• Type of Device: SOLUTIONS
• Manufacturer (Section D): JOHNSON AND JOHNSON VISION SURGICAL, INC.; santa ana CA
• MDR Report Key: 7732906
• MDR Text Key: 115486004
• Report Number: 3004178847-2018-00007
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(17)200907(10)ZC08253
• Combination Product (y/n): Y
• PMA/PMN Number: K040839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,10/29/2020

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 Expiration Date: 09/07/2020
• Device Model Number: 08772X
• Device Lot Number: ZC08253
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 09/12/2018; 10/25/2020
• Supplement Dates FDA Received: 10/28/2018; 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention