MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-10-07 for IOLMASTER 000000-1322-734 manufactured by Carl Zeiss Meditec Ag (jena).
[88940022]
The manufacturer reviewed the pre- and post-op measurement printouts as well as the iol calculation printouts from the device. The calculation of the iol power performed by the device was correct. However, the measurement printout does indicate irregular keratometry readings, therefore it is recommended that a repeat measurement should be taken as precaution. The iolmaster user manual provides information for safety (000000-1322-734_doks_us_280709, page 68): "warning: to obtain consistent results we recommend checking the individual keratometer measurements and carrying out further measurements if necessary. " in addition, the patient's medical history indicates an eye condition (i. E. Blepharitis) that may affect the cornea and tear film integrity. For such patients, care should be taken and repeated measurements are recommended over a longer period of time (i. E. One month) to ensure stability of the keratometry measurements. A number of factors not related to the lolmaster may have influenced the surgical outcome. The quality of keratometry measurements is highly dependent on stable tear film, correct fixation, and wide open eyes. The user manual describes in detail how to perform intraocular lens measurements and calculations, and contains warnings about relevant parameters.
Patient Sequence No: 1, Text Type: N, H10
[88940023]
The healthcare professional (hcp) reported the following: the iolmaster was used for the patient's biometry measurements. An alcon sn6at8 lens with a power of +28. 0d was used. The od post-refractive outcome after a cataract surgery with an intraocular lens (iol) implantation differed -4. 50 d from the target refraction. The hcp made a decision to exchange the iol.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2017-00021 |
| MDR Report Key | 6927515 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-07 |
| Date of Report | 2017-09-07 |
| Date of Event | 2017-08-16 |
| Date Mfgr Received | 2017-09-07 |
| Device Manufacturer Date | 2009-09-14 |
| Date Added to Maude | 2017-10-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. WILLIAM GUSTAFSON |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574689 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG (JENA) |
| Manufacturer Street | CARL ZEISS PROMENADE 10 |
| Manufacturer City | JENA, THUERINGIA 07745 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 07745 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IOLMASTER |
| Generic Name | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED |
| Product Code | HJO |
| Date Received | 2017-10-07 |
| Model Number | NA |
| Catalog Number | 000000-1322-734 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (JENA) |
| Manufacturer Address | CARL ZEISS PROMENADE 10 JENA, THUERINGIA 07745 GM 07745 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-07 |