The FEMTO LDV — Class II medical device recall Z-1272-2018
Terminated recall by SIE AG, Surgical Instrument Engineering, reported 2018-04-04, distributed nationwide. This Correction is being initiated based on a customer complaint received on November 16, 2017 which indicated
| Recall number | Z-1272-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SIE AG, Surgical Instrument Engineering, Port, Switzerland |
| Recall initiated | 2018-01-21 |
| Classified | 2018-03-29 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2018-11-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BE, BR, CA, CH, DE, ES, FR, IL, IN, IQ, IT, JP, LB, MX, MY, PE, PK, PL, PT, RO, RU, SA, SG, TW, ZA |
| Quantity | 125 devices |
| Serial numbers | FLM1003, FLM1008, FLM1009, FLM1046, FLM1092, FLM1093, FLM1135, FLM1179, FLM1182, FLM1188, FLM1225, FLM1274, FLM1320, FLM1326, FLM1364, FLM1407, FLM1464, FLM1502, FLM1545, FLM1554, FLM1591, FLM1592, FLM1640, FLM1686, FLM1724 and 100 more |
Product
The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface. In addition, the FEMTO LDV(TM)Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
Reason for recall
This Correction is being initiated based on a customer complaint received on November 16, 2017 which indicated a complication with a cataract procedure. An investigation completed by the manufacturer determined that although the complication was due to user error improvements could and should be made on our part to improve the usability and performance of our device.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1272-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.