ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Summary
The FDA issued a Class II for ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract by Carl Zeiss Meditec AG. Reason: High friction of the slider can cause the device to stick, or not move as intended..
Details
Source
Device Recall
External ID
Z-1007-2022
Action Date
2022-05-04
Status
Ongoing
Category
device
Product Description
ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Lot/Code Info: Model: 303071-9090-000 Catalog Number: FG-50608 UDI: (01)04049539104496(11)201102(17)231031(10)FG21082410 Lot Number: FG21082410
Quantity Affected: 1225 devices
Reason for Recall
High friction of the slider can cause the device to stick, or not move as intended.
Distribution
U.S.: AL, AR, AZ, CA, CT, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OR, PA, Puerto Rico, SC, TN, TX. UT, VA, WA, and WV O.U.S.: Not provided
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-16
Company
Oberkochen
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 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Carl Zeiss Meditec AG has 12 FDA actions in our database, including 1 recall and 11 clearances.
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 (Carl Zeiss Meditec AG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Carl Zeiss Meditec AG have FDA actions?
Carl Zeiss Meditec AG has 12 FDA actions in our database, including 1 recall and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1007-2022" 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