Summary
The FDA issued a Class II for OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4 by Haag-Streit USA Inc. Reason: Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off.
Details
Source
Device Recall
External ID
Z-0477-2022
Action Date
2022-01-19
Status
Ongoing
Category
device
Product Description
OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
Lot/Code Info: Serial no. 0005, 0023
Quantity Affected: 2 devices quarantined in US
Reason for Recall
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
Distribution
US Nationwide distribution in the states of OH, IN.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-03
Company
Mason, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 106 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Haag-Streit USA Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Haag-Streit USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Haag-Streit USA Inc have FDA actions?
Haag-Streit USA Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0477-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29