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SL 115 Classic
Carl Zeiss Meditec AG · Model SL 115 Classic · UDI-DI 04049471090178
1
510(k) clearances
217
Adverse events
8
Recalls
56
Facilities
Description
The SL 115 Classic Slit Lamp is a AC-powered slit lamp biomicroscope intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used to aid in the diagnosis of disease or trauma which affect the structural properties of the anterior eye segment. The optional SL cam 5.0 is a digital imaging solution that allows the user to take images and video sequences for documentation purposes of the anterior eye segment during slit lamp examinations.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-15 | Haag-Streit USA Inc | Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI). |
| 2020-12-07 | Carl Zeiss Meditec AG | When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the p |
| 2018-06-25 | Carl Zeiss Meditec AG | Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures |
| 2016-07-01 | Nidek Inc | Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement. |
| 2015-10-27 | Carl Zeiss Meditec AG | IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data. |
| 2015-10-27 | Carl Zeiss Meditec AG | IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data. |
| 2013-10-23 | Carl Zeiss Meditec, Inc. | The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database |
| 2013-10-23 | Carl Zeiss Meditec, Inc. | The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.