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Ophthalmoscope, Ac-Powered
FDA product code HLI · Class 2 · Ophthalmic
305
Registered devices
25
Adverse events
7
Recalls
87
510(k) clearances
Devices with this code
Welch Allyn, Inc. — WELCH ALLYN, INC.LED SLIMLINE STUDENT KIT — KEELER LIMITEDWelch Allyn, Inc. — WELCH ALLYN, INC.Amico Diagnostic Wallboard — Amico Diagnostic IncorporatedAmico Diagnostic Station — Amico Diagnostic IncorporatedCANON INC. — CANON INC.Welch Allyn, Inc. — WELCH ALLYN, INC.OMEGA 500 LED — Heine Optotechnik GmbH & Co. KGWelch Allyn, Inc. — WELCH ALLYN, INC.LITHIUM DOUBLE CHARGER — KEELER LIMITEDiStand — OPTOVUE, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Amico Diagnostic Wallboard — Amico Diagnostic IncorporatedWelch Allyn, Inc. — WELCH ALLYN, INC.API 2/2 IN CARTON — KEELER LIMITEDAmico Diagnostic Station — Amico Diagnostic IncorporatedVantage Plus LED Corded — KEELER LIMITEDAmico Diagnostic Station — Amico Diagnostic IncorporatedWelch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Amico Diagnostic Wallboard — Amico Diagnostic IncorporatedAmico Diagnostic Station — Amico Diagnostic IncorporatediVue — OPTOVUE, INC.Amico Diagnostic Wallboard — Amico Diagnostic Incorporated
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-11-03 | Haag-Streit USA Inc | Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off |
| 2017-07-27 | Optovue, Inc. | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). |
| 2017-07-27 | Optovue, Inc. | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). |
| 2016-03-16 | Optovue, Inc. | A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database that may display images of the same eye rather than right and lef |
| 2013-05-14 | Optovue, Inc. | Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from |
| 2009-07-31 | Carl Zeiss Meditec Inc | Mis-labeled image. A bug in version 6.0.0 software and 6.0.0 software kit used with Stratus OCT Model 3000 can produce a report that incorrectly labels OD or O |
| 2008-01-08 | Keeler Instruments Inc | Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device. Firm is on import alert 89-04 and released product. |
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