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U.S. Department of Health and Human Services

Class 2 Device Recall VisuMax Femtosecond Laser

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  Class 2 Device Recall VisuMax Femtosecond Laser see related information
Date Initiated by Firm December 06, 2018
Create Date December 13, 2019
Recall Status1 Terminated 3 on February 02, 2021
Recall Number Z-0680-2020
Recall Event ID 83913
PMA Number P150040 
Product Classification Femtosecond laser system for refractive correction - Product Code OTL
Product VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction.

Catalog Number 0000000-1345-518

Product Usage: The VisuMax Femtosecond Laser is a precision ophthalmic surgical laser designed for the creation of incisions in the cornea. The VisuMax Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia. This device is intended for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia >=-1.00 D to <=-8.00 D, with <=-0.50 D cylinder and MRSE <=-8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change of <=0.50 D MRSE.
Code Information Serial Numbers:  988123  988132  1008162  1008173  1021446  1080079  1089462  1089463  1105752  1105765  1105766  1105773  1115905  1115920  1115926  1124475  1124476  1124478  1124480  1124483  1136403  1143784  1143795  1154532  1154534  1156046  1156048  1156053  1156059  1157773  1159423  1159430  1161751  1161753  1161756  1161763  1161764  1161765  1164588  1165541  1165545  1165548  1165550  1165552  1165553  1165554  1165555  1165562  1165563  1165565  1168236  1168239  1168243  1168244  1168245  1168246  1168254  1171082  1173826  1173832  1173838  1182193 1182194 1182195 1182196 1182198 1186711 1186713 1192911 1192914 1196018  
Recalling Firm/
Manufacturer		 Carl Zeiss Meditec, Inc.
5160 Hacienda Dr
Dublin CA 94568-7562
For Additional Information Contact Michael Schmidt
925-557-4100
Manufacturer Reason
for Recall		 VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a software issue. In case of a suction loss during treatment the software allows the user to choose the option immediate restart or restart treatment. Suction loss can occur in phase 1 through phase 5. The software defect refers to Phase 2 (between 10% and 100% of lower lenticule cut) only. The software offers a flap cut, but due to the software issue it performs a cap cut instead of a flap cut if the user proceeds.
FDA Determined
Cause 2		 Software design
Action Consignees were notified with an Urgent Medical Device Recall letter dated 12/06/2019. The letter identified affected devices, described the software issue, and provided direction on what steps to take with suction loss in phase 2, until a software update is available. A response form was asked to be returned. Questions can be directed to 877-486-7473.
Quantity in Commerce 66 units
Distribution US nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = OTL and Original Applicant = Carl Zeiss Meditec, Inc.
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