MAUDE Adverse Event Report: HAAG-STREIT AG GOLDMANN TONOMETER PRISM; TONOMETER PRISM (21 CFR 886.1930)

Model Number NONE

Device Problems Device Reprocessing Problem (1091); Difficult to Insert (1316); Contamination /Decontamination Problem (2895)

Patient Problem Eye Burn (2523)

Event Date 12/28/2015

Event Type  Injury  

Manufacturer Narrative

We received a complaint about tonometer prisms from an o.D.In (b)(6) on 28th december 2015.As there were three corneal burns and prisms bloated as documented and conveyed to haag-streit (b)(4).Haag-streit (b)(4) product manager, (b)(4) contacted (b)(4) to discuss the concerns above to acquire further information about the disinfection process they are utilizing and the bloating of the tonometer prisms.Currently per haag-streit (b)(4) the problem appears to be abnormal use of the medical device per the instructions for use provided by haag streit (b)(4).The current situation is the hospital sps personnel have disinfected all of the tonometer prisms due to concerns mentioned above.It appears the instructions for use is not being followed as written by haag-streit (b)(4).Secondly, the end user recently hired 3 new technicians.Additional information is needed as well as returning the affected medical devices (tonometers prisms) from (b)(6) medical center or the (b)(6) to haag-streit (b)(4) for further investigation into these problems.Important information concerning this medwatch: haag-streit usa was initially unsuccessful in setting up our webtrader account due to configuration issues.This has taken several months to correct.We contracted an it group (clearlogic) to assist us to complete the install.We were in constant contact with several people from the esg help desk and the cdrh in attempts to correct this concern through the entire configuration process.Haag-streit usa received approval for emdr production test submissions as of 04/25/2016.If you have any questions or concerns regarding this medwatch (emdr) please contact us and we will provide any further information to assist the fda.Respectfully, (b)(4).

Event Description

We have recently been forced to have our hospital's sterile processing service (sps) disinfect all of our tonometer prisms.For a while they were following your recommended sodium hypochlorite protocol, but they just hired three new technicians.We now have produced three corneal burns and have frequently rejected prisms that had a residue on the ocular surface.If that wasn't bad enough, we now have more than 11 prisms that will no longer fit into the retaining ring on the tonometer arm.They are bloated.I have asked sps if they were autoclaving the prisms; they have denied the use of steam.So, what else could cause this effect.

• Brand Name: GOLDMANN TONOMETER PRISM
• Type of Device: TONOMETER PRISM (21 CFR 886.1930)
• Manufacturer (Section D): HAAG-STREIT AG; gartenstadtstrasse 10; koeniz, CH-30 98; SZ CH-3098
• Manufacturer (Section G): HAAG-STREIT AG; gartenstadtstrasse 10; koeniz, CH-30 98; SZ CH-3098
• Manufacturer Contact: beat hugi ; gartenstadtstrasse 10; koeniz, CH-30-98 ; SZ CH-3098 ; 4131978011
• MDR Report Key: 5623928
• MDR Text Key: 44154394
• Report Number: 1000176188-2016-00001
• Device Sequence Number: 1
• Product Code: HKY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NONE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2015,04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NONE
• Device Catalogue Number: 1902615
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/05/2016
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/28/2015
• Date Manufacturer Received: 12/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other