Recall record at a glance
| Official record | Z-0108-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Carl Zeiss Meditec AG |
| Report date | Oct 24, 2018 |
| Recall initiation date | Jun 25, 2018 |
| Quantity | 1 |
| Location | Jena, N/A, Germany |
Official product description
Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
Why the product was recalled
Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the anterior and posterior segments of the eye.
Distribution information
US: CA (Mountain View and San Jose) A single system. No distributed OUS.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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