CAT 3000 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-12-13 for CAT 3000 * manufactured by Rayban Sun Optics, Inc..

Event Text Entries

[17111171] Reporter was wearing the pair while driving along a local interstate. Reporter heard a small click and felt something enter eye preventing reporter from seeing through that eye. Reporter then pulled off to the hard shoulder and removed the sunglasses. With a small mirror reporter was able to remove an extremely small black piece from eye. (it seemed to have lodged behind the contact lens). On further inspection reporter noticed that the rim around the left lens of the sunglasses had cracked. Reporter can only assume that the debris in eye came from the crack in the sunglasses or dirt lodged around the rim of the glasses. At no time during the entire episode was there any impact to the sunglasses. Reporter's eye was somewhat sore from the incident. After the incident reporter met with an ophthalmologist friend who examined the eye. She suggested that there was scarring of the cornea. At the time reporter was still in some pain. Reporter then contacted the mfr by phone. Reporter explained the nature of the injury and the circumstances surrounding the occurrence. It was explained that rayban had been acquired by luxottica and the policy was that reporter should return the sunglasses to the service dept along with a check or money order in the amount of $10. 00 plus tax in order for the co to address the problem. According to the reporter, co seemed to have little or no concern regarding the injury. Reporter returned the sunglasses to the mfr by registered mail but did not include the requested $10. 00. Reporter retained the small piece of plastic recovered from eye. Subsequently reporter spoke with several people at the co in an attempt to get the issue resolved. Eventually reporter spoke with a rep of luxottica. She stated that since reporter had received treatment from a friend for the injury and that a medical report was not available she could and would not take any further action. Reporter has received no contact from the co other than that which reporter initiated. The sunglasses are still in the possession of the mfr. Reporter still finds it difficult to tolerate a contact lens in left eye. These sunglasses were received by reporter as a christmas gift in december of 1998.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1017762
• MDR Report Key: 255514
• Date Received: 1999-12-13
• Date of Report: 1999-12-10
• Date of Event: 1999-09-21
• Date Added to Maude: 1999-12-23
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CAT 3000
• Generic Name: SUNGLASSES
• Product Code: HQY
• Date Received: 1999-12-13
• Model Number: CAT 3000
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 247425
• Manufacturer: RAYBAN SUN OPTICS, INC.
• Manufacturer Address: 5335 CASTROVILLE RD. SAN ANTONIO TX 78227 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-12-13