# FDA recall Z-1674-2022

> **Oculus Optikgeraete GMBH** · Class II · device recall initiated 2022-07-08.

## Product

Pentacam HR REF 70900.  Used to image the anterior segment of the eye.

## Reason for recall

Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs

## Distribution

U.S.: AL, AR, AZ, CAQ, CO, CT, FL, GA, HI, IA, ID, IL, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, and WY  O.U.S.: N/A

## Key facts

- **Recall number:** Z-1674-2022
- **Recalling firm:** Oculus Optikgeraete GMBH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-07-08
- **Report date:** 2022-09-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wetzlar, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1674-2022

## Citation

> AI Analytics. FDA recall Z-1674-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1674-2022. Source: US FDA. Licensed CC0.

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