Oculus Optikgeraete GMBH: Pentacam HR REF 70900. Used to image the anterior segment of the eye.

Is my product affected?

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

• UPC 04049584000026

Check against the official notice below — it lists the full affected range.

What happened

The Pentacam HR (Model 70900) manufactured by Oculus Optikgeraete GMBH is subject to a recall due to a software issue affecting 19 systems. The device is used to image the anterior segment of the eye and assist in planning intraocular lens (IOL) implants. When using the IOL calculator function with toric IOLs, the printout may not accurately reflect the alignment axis and incision position needed for proper lens placement.

The affected devices run software versions 1.26r26 and 1.26r27 and are identified by specific serial numbers beginning with "70900." The recall involves systems distributed across numerous U.S. states and Puerto Rico. The source document does not specify what remedy is available to consumers who possess an affected device.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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 Quantity: 19 systems with affected software Lot/code info: Software version: 1.26r26 and 1.26r27 Model Number: 70900 UDI-DI Code: 04049584000026 Serial Numbers: 70900 0574 8160 70900 0925 0240 70900 0995 2250 70900 1664 8130 70900 1995 2250 70900 3451 7060 70900 3795 2250 70900 3965 1270 70900 4041 7010 70900 4172 2110 70900 4795 2250 70900 6234 7150 70900 7552 1160 70900 7952 1180 70900 8804 6140 70900 8813 3140 70900 9142 0121 70900 9695 2250 70900 9795 2250

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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All FDA (Device enforcement) recalls