Z-3272-2018Class II

Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Field Elite Pack, REF SE5425MV...

Name: Z-3272-2018 Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Field Elite Pack, REF SE5425MV...
Creator: Bausch & Lomb Inc
Published: 2018-08-08
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2018-08-08 / Terminated / root cause: manufacturing process

FDA source

Bausch & Lomb Inc began a recall of Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Field Elite Pack, REF SE5425MV (containing the Stellaris Elite 25 GA Vit Cutter... on 2018-08-08. FDA classified it as Class II and gives the reason as "The back cap separates from the body of the vitrectomy cutter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3272-2018
Classification: Class II
Status: Terminated
Initiated: 2018-08-08
Posted: 2018-09-27
Terminated: 2019-08-28
Recalling firm: Bausch & Lomb Incorporated
Product: Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Field Elite Pack, REF SE5425MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.
Product code: HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Reason for recall: The back cap separates from the body of the vitrectomy cutter.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Recall letters flagged URGENT MEDICAL DEVICE VOLUNTARY RECALL dated 8/8/2018 were issued 8/8/2018 via certified mail return receipt to the U.S. consignees. Letters for foreign consignees were dated 8/7/2018 and were flagged URGENT FIELD SAFETY NOTICE.
Quantity in commerce: 67 cases
Distribution: Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.
Product codes and lots: Lot numbers W0149, exp. 2/26/2019; W0190, exp. 2/28/2019; W0785, exp. 5/11/2019; W0874, exp. 6/4/2019; and W1108, exp. 7/5/2019, UDI 00757770059430.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3272-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3265-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27
Z-3266-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27
Z-3267-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27
Z-3268-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27
Z-3269-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27
Z-3270-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27
Z-3271-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27
Z-3272-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27
Z-3273-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27
Z-3274-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27
Z-3275-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27
Z-3276-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27
Z-3277-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27

Product code HQE

K162342Class IIStellaris Elite Vision Enhancement SystemBausch+Lomb / cleared 2017-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)