UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-09 for UNKNOWN manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[188390170] Age/date of birth: unknown/ not provided. Brand name: unknown as product serial number was not provided. Model number: model number is unknown, as product serial number was not provided. Catalog number: catalog number is unknown, as product serial number was not provided. Expiration date: unknown as product serial number was not provided. Serial number: unknown as the information was not provided. Udi number: udi # is unknown as product serial number was not provided. If explanted; give date: not applicable as the iol remains implanted in the patient's eye. Pma/510(k) number: unknown as iol product serial number information was not provided. The product serial number for this device is not available and the lens also remains implanted; therefore, no further investigation can be performed. If there is any further relevant information received, a supplemental medwatch report will be filed. Device manufacture date: unknown as product serial number was not provided. (b)(4). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10

[188390171] At the 6-month clinical masked study visit, the best corrected distance visual acuity (bcdva) of both eyes (ou) reported to be 20/16. The first eye, left eye (os) surgery was (b)(6) 2019 and second eye, right eye (od) was (b)(6) 2019. The patient reported of the ocular visual symptoms of being moderately bothered by starbursts as well as being very bothered by halos and glare. The patient has difficulty only when driving at night. There was no patient complication and/or related injury reported. There was no surgical intervention planned. No additional information was reported. The patient had bilateral implants. This report is for the event associated with the patient's left eye (os). A separate report will be filed for the event with the patient's right eye (od).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9614546-2020-00111
• MDR Report Key: 9809285
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-03-09
• Date of Report: 2020-03-09
• Date of Event: 2020-02-10
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-02-10
• Date Added to Maude: 2020-03-09
• 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: 3
• Initial Report to FDA: 3
• 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: VAN SWIETENLAAN 5
• Manufacturer City: GRONINGEN 9728NX
• Manufacturer Country: NL
• Manufacturer Postal Code: 9728 NX
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: UNKNOWN
• Generic Name: MULTIFOCAL IOLS
• Product Code: MFK
• Date Received: 2020-03-09
• Model Number: UNKNOWN
• Catalog Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• 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: 2020-03-09
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-03-09