Haag-Streit USA Inc OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off

Recommended Action

Per FDA guidance

Haag-Streit USA send out field safety notice 2021-10/01 on November 03, 2021. Actions to be taken by the customer/user: Should one or more continuous straight lines be displayed on the screen of the OCT camera during an operation on the posterior segment of the patient's eye (see picture in the notification), the described risk possibly exists. 1. Switch off the OCT camera immediately (menu OCT -> Switch off). 2. The OCT camera is not permitted to be used any more. Please contact your responsible country representative. 3. Perform the software update of the OCT camera. You will receive the new software version via your local representative, who will correct the error. 4. Please fill out and return the enclosed response form as soon as the software update has been performed 5. Please ensure that all users of the products mentioned are aware of and receive this urgent safety information. If you have passed the products to third parties, please forward a copy of this information and inform the contact person listed in the notification. 6. Software update organization will be performed by Haag-Streit USA, Inc. Please contact Mike Dietz at (513) 486-1513 or via email: fieldsafetynotice@haag-streit-usa.com for questions concerning this procedure.