# FDA recall Z-3274-2018

> **Bausch & Lomb Inc** · Class II · device recall initiated 2018-08-08.

## Product

Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-Field Elite Pack, REF SE5523MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.

## Reason for recall

The back cap separates from the body of the vitrectomy cutter.

## 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.

## Key facts

- **Recall number:** Z-3274-2018
- **Recalling firm:** Bausch & Lomb Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-08
- **Report date:** 2018-10-03
- **Termination date:** 2019-08-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Louis, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3274-2018

## Citation

> AI Analytics. FDA recall Z-3274-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-3274-2018. Source: US FDA. Licensed CC0.

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