LINT FREE EYE SPEARS 9002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2003-10-15 for LINT FREE EYE SPEARS 9002 manufactured by Hurricane Medical.

Event Text Entries

[363499] Lint free eye spear used during lasik surgery may be causing increased incidence of dlk, although not conclusive according to surgeon.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1064005-2002-00004
• MDR Report Key: 548037
• Report Source: 01,05,06
• Date Received: 2003-10-15
• Date of Report: 2003-10-15
• Date of Event: 2002-05-20
• Date Mfgr Received: 2002-05-20
• Device Manufacturer Date: 2002-04-01
• Date Added to Maude: 2004-10-13
• 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: 0
• Manufacturer Street: 2331K 63RD AVE EAST
• Manufacturer City: BRADENTON FL 342003
• Manufacturer Country: US
• Manufacturer Postal: 342003
• Manufacturer Phone: 9417510588
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LINT FREE EYE SPEARS
• Generic Name: OPHTHALMIC SPONGE
• Product Code: HOZ
• Date Received: 2003-10-15
• Model Number: 9002
• Catalog Number: 9002
• Lot Number: UNK
• ID Number: NONE
• Device Expiration Date: 2007-05-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 537490
• Manufacturer: HURRICANE MEDICAL
• Manufacturer Address: 2331K 63RD AVENUE EAST BRADENTON FL 34203 US
• Baseline Brand Name: LINT FREE EYE SPEARS
• Baseline Generic Name: OPHTHALMIC SPONGE
• Baseline Model No: 9002
• Baseline Catalog No: 9002
• Baseline ID: NONE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2003-10-15