MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. COMPLETE EASY-RUB; SOLUTIONS

Model Number	09424X
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Irritation (1941); Red Eye(s) (2038)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Alternative report identification number: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Consumer reported that she experienced redness and irritation in her eyes after using complete multi purpose solution.Reportedly, this was her first time using the product.Additionally, this was the initial use of the reported bottle of solution.She went to her optometrist and was prescribed antibiotics to resolve the redness and irritation.No further information was provided.
Additional Manufacturer Narrative
Alternative report identification number: (b)(4).Device evaluation: product testing could not be performed as the product was not returned.The consumer¿s reported event could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation, no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional 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
• Common Device Name: SOLUTIONS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 8276627
• Report Number: 3004178847-2019-00004
• Device Sequence Number: 1557365
• Product Code: LPN
• UDI-Device Identifier: 20827444000656
• UDI-Public: (01)20827444000656(17)191030(10)ZC08034
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K014202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2020
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/30/2019
• Device Model Number: 09424X
• Device Lot Number: ZC08034
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 02/24/2019; 10/25/2020
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 04/29/2019; 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005