FDA recall Z-1672-2022

Product

Pentacam AXL Wave REF 70020. 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

Status

Ongoing

Initiation date

2022-07-08

Report date

2022-09-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wetzlar, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1672-2022