QUANTUM OPTICS SILHOUETTE READERS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-06 for QUANTUM OPTICS SILHOUETTE READERS manufactured by Quantum Optic's.

Event Text Entries

[4318275] When i bumped into something wearing reading glasses, i cut my face in two places near my left eye. I am concerned that this type of reading glasses, which have protruding screws and nuts on the back side, could cause substantial eye damage in an accident. I have lost the reading glasses that caused the injury, but think they are the ones here: (b)(6). If the image is rotated you can clearly see the protruding screws on the back of the lenses. I think they were these silhouette p131 glasses, and i did buy them at (b)(6). If not identical to these, these show the exact same kind of protruding screws. The screws protrude past the nuts and have sharp edges. Even the nuts themselves, if the screws were flush with the tops of the nuts, are sharp and protrude substantially past the back of the lenses. I also have another pair of iline brand reading glasses purchased from (b)(6) made the same way. These are marked"; outside of left temple: "iline"; inside of right temple: "i 017 onyx edge glow +2. 00 pd 62mm d". I have also seen foster grant brand reading glasses at a (b)(6) pharmacy that are made the same way. I am concerned that someone is going to have substantial eye injury from wearing reading glasses with these sharp screws sticking out of the back of the lenses. Quantum optics silhouette readers p131 (b)(6). Purchase date: (b)(6) 2013. The product was not damaged before the incident. The product was not modified before the incident. (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5034874
• MDR Report Key: 3672535
• Date Received: 2014-03-06
• Date of Report: 2014-02-27
• Date of Event: 2013-12-15
• Date Added to Maude: 2014-03-12
• 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: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: QUANTUM OPTICS SILHOUETTE READERS
• Generic Name: READING GLASSES
• Product Code: HQZ
• Date Received: 2014-03-06
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: QUANTUM OPTIC'S

Device Sequence Number: 2

• Brand Name: ONYA EDGE GLOW
• Generic Name: READING GLASSES
• Product Code: HQZ
• Date Received: 2014-03-06
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 2
• Device Event Key: 0

Device Sequence Number: 3

• Brand Name: FOSTER GRANT
• Generic Name: READING GLASSES
• Product Code: HQZ
• Date Received: 2014-03-06
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: FOSTER GRANT

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2014-03-06