CORRECTIVE EYEGLASS LENSES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-13 for CORRECTIVE EYEGLASS LENSES manufactured by .

Event Text Entries

[5517893] This complaint is for (b)(6) not following 21 cfr 820. Since ordering new glasses on (b)(6) 2014, the lab has manufactured and sent glasses at least 3 times where the prescriptions are not correct. As of (b)(6) 2015, i still have not received lenses with the correct prescription. I do not understand how the lab's quality systems are not able to catch that lenses are being manufactured with the incorrect prescription and these lenses are being sent to customers. My eye doctor caught the mistake at least twice that i'm aware of and i noticed it once and had to send the lenses back to be remanufactured. My eye doctor office that may have more info is (b)(6). I have 15 years working in the (b)(6) systems. I believe that my expectations for this device manufacture are aligned with 21 cfr 820. On (b)(6) 2014, lenses were returned to the lab because prism was left out of the lenses. On (b)(6) 2015, lenses were returned to the lab because there was incorrect prism in lenses. On (b)(6) 2015, lenses were returned to the lab because prism was left out of the lenses: (b)(6).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5040887
• MDR Report Key: 4541679
• Date Received: 2015-02-13
• Date of Report: 2015-02-13
• Date of Event: 2015-02-13
• Date Added to Maude: 2015-02-25
• 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 Details

• Brand Name: CORRECTIVE EYEGLASS LENSES
• Generic Name: LENSES
• Product Code: HQG
• Date Received: 2015-02-13
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2015-02-13