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

Model Number 09424X

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

Patient Problems Corneal Scar (1793); Keratitis (1944); Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device evaluation: the solution was not returned to the manufacturer; therefore testing could not be performed and the consumer's reported complaint 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, including incoming chemical materials testing, primary materials inspection, product physical appearance inspection, bulk and finished product chemical testing and microbial testing, sterilization records, environment monitoring and water system monitoring.There was no non-conformance related to this complaint.In conclusion, reported lot was deemed acceptable for release per material and products release.No other complaints were found under this lot number.Labeling review: the directions for use (dfu) adequately provides the customer with instructions and precautions, along with warnings for the proper handling and use of the product.Based on the investigation results, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision has been submitted.

Event Description

Report was received from the (b)(6) regarding a male consumer¿s adverse reaction to his right eye after using complete¿ multi-purpose solution.The consumer had been using the brand of contact lens for a year and had recently purchased 4 boxes of contact lens from the optical shop.Shortly after using this recent batch of contact lens, the male consumer developed an eye problem and sought medical advice.He was reportedly diagnosed with severe pseudomonas keratitis in the right eye, leaving a white central scar that reduced his bcva (best corrected visual acuity) to 6/60 and his doctor recommended corneal surgery.The consumer has discontinued use of both the contact lenses and solution.No additional information provided.As three bottles were reported being used a separate mdr will be provided for each lot/bottle.This report represents lot zb10054, the second of two reports for this lot number.

• Brand Name: COMPLETE EASY-RUB
• Type of Device: SOLUTIONS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; 4th ave; hz econ/tech develop. zone; hangzhou 31001 8; CN 310018
• Manufacturer Contact: cathey ozuna ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478372
• MDR Report Key: 7474426
• MDR Text Key: 106954383
• Report Number: 3004178847-2018-00003
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(17)191111(10)ZB10054
• Combination Product (y/n): N
• Reporter Country Code: SG
• PMA/PMN Number: K014202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/11/2019
• Device Model Number: 09424X
• Device Lot Number: ZB10054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention