UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for UNKNOWN manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[186168477] Age/date of birth: unknown/not provided. Sex/gender: unknown/not provided. Date of event: unknown, not provided. Brand name: unknown as product serial number was not provided. Model number: unknown as product serial number was not provided. Catalog number: 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 implanted; give date: unknown/ not provided. If explanted; give date: not applicable as the iol remains implanted in the patient's eye. (b)(6). 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. All pertinent information available to johnson and johnson surgical vision has been submitted.
Patient Sequence No: 1, Text Type: N, H10


[186168478] It was reported that a fiber/matter was discovered inside the eye, on the lens in four (4) occasions. The fiber was removed and it was described by the doctor as being similar to silicone or plastic looking, soft and sticky. It was indicated that the lens remains implanted and there is no plan for an explant procedure. There were no surgical intervention such as vitrectomy, incision enlargement, or sutures required. It was indicated that no samples were kept in these cases. No additional information was provided. This report is three (3) out of four. Separate reports are being submitted for the other three events.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2648035-2020-00300
MDR Report Key9901763
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-30
Date of Report2020-03-30
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-03-03
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSOMYATA NAGPAL
Manufacturer Street1700 EAST ST. ANDREW PLACE
Manufacturer CitySANTA ANA CA 92705
Manufacturer CountryUS
Manufacturer Postal92705
Manufacturer Phone7142478200
Manufacturer G1JOHNSON & JOHNSON SURGICAL VISION, INC.
Manufacturer StreetROAD 402 NORTH, KM 4.2 ANASCO INDUSTRIAL PARK
Manufacturer CityANASCO PR 00610
Manufacturer CountryUS
Manufacturer Postal Code00610
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameUNKNOWN
Generic NameMONOFOCAL IOLS
Product CodeHQL
Date Received2020-03-30
Model NumberUNKNOWN
Catalog NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerJOHNSON & JOHNSON SURGICAL VISION, INC.
Manufacturer Address1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705

Device Sequence Number: 101

Product Code---
Date Received2020-03-30
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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