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 2017-02-17 for IOLMASTER 500 000000-1692-983 manufactured by Carl Zeiss Meditec Ag (jena).
[67804255]
A zeiss field service engineer inspected the device and confirmed that the iolmaster 500 is operating per manufacturer specification. The manufacturer evaluated the patient measurement and iol calculation printouts from the device. The measurement printout does not show any abnormalities. During the investigation, the customer informed that the lens constants for the selected iol were entered manually in the iolmaster 500 and the wrong acd constant was entered in the holladay 2 formula field. By reviewing the calculation printout, the manufacturer confirmed that the acd constant for holladay 1 was entered into the holladay 2 formula field, which caused the incorrect lens power result. When using the correct acd constant of 5. 838, the calculated lens power would have been 23. 0 d for the iol; instead acd constant 2. 070 was used, which led to a lens power of 17. 0 d. How to use the lens constants is described in the user manual. For example, on page 25 of user manual 000000-1692-983 it is stated "only lens constants which have been optimized for the iolmaster should be used" and "you can enter your own constants on the basis of experience or access third party data". On pages 26-30, the user manual provides step-by-step instructions for both of these methods.
Patient Sequence No: 1, Text Type: N, H10
[67804256]
The health care professional (hcp) reported the following: the os post refractive outcome after a cataract surgery with an intraocular lens (iol) implantation differed +4. 0 d from the target refraction. The alcon acrysof iq restor model sv25t0 lens with a power of 17. 0 d was used. The hcp informed that a re-op was performed to exchange the lens. The same lens with a power of 23. 0 d was used for the re-op. The iolmaster was used for the original biometry measurements and iol calculations as well as for the second biometry measurements and calculations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2017-00003 |
| MDR Report Key | 6341762 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-17 |
| Date of Report | 2017-02-17 |
| Date of Event | 2017-01-17 |
| Date Mfgr Received | 2017-01-19 |
| Device Manufacturer Date | 2012-07-03 |
| Date Added to Maude | 2017-02-17 |
| 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, THURINGIA 07745 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 07745 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IOLMASTER 500 |
| Generic Name | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED |
| Product Code | HJO |
| Date Received | 2017-02-17 |
| Model Number | NA |
| Catalog Number | 000000-1692-983 |
| 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, THURINGIA 07745 GM 07745 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-17 |