COMPLETE 9424X

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-25 for COMPLETE 9424X manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[186315086] Alternative report identification number (b)(4). Device evaluation: the product was returned to the manufacturing site for evaluation. All the results met the product specification. No product failure identified. 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 other complaints were received for this production order in the previous 12 months. Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10

[186315087] A consumer reported that after using complete multipurpose solution, she temporarily lost sight in both eyes. She visited her doctor and was prescribed drops. She tried using complete multipurpose solution again and the symptoms returned. Through follow-up the consumer explained that what she meant by vision was lost is severe blurry vision with pain and was unable to read. Her left eye was affected the most so she would use her right eye. She saw her physician who prescribed prednisolone drops. She used the drops for 3 months without contacts. Per the consumer, the doctor? S diagnosis was dry spots on her cornea. The consumer has no history of dry eye or other eye issues. The consumer further explained that once her eyes felt better after using the prescribed drops, she tried using the complete solution again. This time her right eye was more the problem. Consumer has worn contacts for 7 years. She wears different brands of monthly disposable soft contact lenses. She does not shower or swim in them. Consumer explained that when she went back to using her previous solution, she did not experience any issues. She is afraid that there is still something wrong with her eyes. The consumer reports she first opened the product in may and symptoms began (b)(6) 2019, it was the first time she has used this product. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3004178847-2020-00004
• MDR Report Key: 9630378
• Report Source: CONSUMER
• Date Received: 2020-01-25
• Date of Report: 2020-03-26
• Date of Event: 2019-06-01
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-02-27
• Date Added to Maude: 2020-01-25
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: SOMYATA NAGPAL
• Manufacturer Street: 1700 EAST ST. ANDREW PLACE
• Manufacturer City: SANTA ANA CA 92705
• Manufacturer Country: US
• Manufacturer Postal: 92705
• Manufacturer Phone: 7142478200
• Manufacturer G1: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Manufacturer Street: 4TH AVE HZ ECON/TECH DEVELOP. ZONE
• Manufacturer City: HANGZHOU 310018
• Manufacturer Country: CN
• Manufacturer Postal Code: 310018
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: COMPLETE
• Generic Name: SOLUTIONS
• Product Code: LPN
• Date Received: 2020-01-25
• Returned To Mfg: 2020-01-05
• Model Number: 9424X
• Lot Number: ZD05205
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Age: DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Manufacturer Address: 1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-01-25
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-01-25