GOLDMANN APPLANATION TONOMETRY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-16 for GOLDMANN APPLANATION TONOMETRY manufactured by S4 Optik Llc.

Event Text Entries

[50124050] My eyes were healthy before (b)(6) 2015. I went to (b)(6) for vision testing, so i can buy a new pair of eyeglasses. I was attended by an exchange student from (b)(4). She was very inexperienced. She did the contact type goldmann applanation tonometry on me asking me not to move my eye but pressing the device hard against my eyes. The clinical summary showed that there are mild arc stain mark of tonometry, i. E. , showing damage done to my cornea. She then did eyelid eversion and touched the eyelid of my left eye with the tip of a cotton applicator. I swayed my head as it was unannounced touching. The tip scratching my left cornea or conjunctive. Then, she instilled mydrin-p (santen, (b)(4)) one drop on each of my eyes for dilatory fundus exam. Mydrin-p contained 0. 5% of phenylephrine which was found cytotoxic in a recent study by (b)(6), et al 2016 (actually its cytotoxic properties was found as early as in 1979). As a result, my corneal epithelial nociceptors/sub-epithelial nerve plexus was altered causing spontaneous pain everyday and loss of corneal equilibrium, persistently inflamed conjunctive and lacrimal caruncle - the eye condition is called ophthalmodynia (with reduction of tear production).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5063510
• MDR Report Key: 5808306
• Date Received: 2016-07-16
• Date of Report: 2016-07-16
• Date of Event: 2015-07-28
• Date Added to Maude: 2016-07-20
• 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: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: GOLDMANN APPLANATION TONOMETRY
• Generic Name: GOLDMANN APPLANATION TONOMETRY
• Product Code: HKY
• Date Received: 2016-07-16
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: S4 OPTIK LLC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Deathisabilit	2016-07-16