Eye imaging device software defect affects surgical planning calculations
Pentacam eye imaging devices with certain software versions have a bug that causes inaccurate surgical planning printouts for toric intraocular lens procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving a software calculation defect with no reported illnesses or injuries. This meets the High severity criterion: a risk-of-harm surgical planning product where injury has not yet been reported.
Plain-English summary
The FDA has identified a software issue in certain Pentacam AXL (REF 70100) and Pentacam HR (REF 70900) eye imaging devices manufactured by Oculus Optikgeraete GMBH. These devices are used to image the anterior segment of the eye and calculate measurements for intraocular lens (IOL) placement during cataract surgery.
The software defect affects the IOL calculator printout, which often does not accurately reflect the alignment axis and incision position when planning toric IOLs (specialized lenses used to correct astigmatism). This could lead to incorrect surgical planning if the printout information is relied upon.
92 systems with software versions 1.26r26 and 1.26r27 are affected and have been distributed across multiple U.S. states and Puerto Rico.
Patients and healthcare providers with affected devices should contact Oculus Optikgeraete GMBH or the FDA for updated software or additional guidance.
The recalled product
- Product
- Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
- Manufacturer
- Oculus Optikgeraete GMBH
- Hazard
- software-defect
- calculation-error
Distribution
Distributed in 36 states:
- AL
- AR
- AZ
- CO
- CT
- FL
- GA
- HI
- IA
- ID
- IL
- KS
- KY
- MD
- ME
- MI
- MN
- MO
- MS
- NC
- NE
- NH
- NJ
- NM
- NY
- OH
- PA
- SC
- SD
- TN
- TX
- UT
- VA
- WA
- WI
- WY
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