MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-04-07 for IOLMASTER 500 000000-1794-857 manufactured by Carl Zeiss Meditec Ag (jena).
[72175055]
The customer confirmed that the iolmaster 500 passed the daily calibration checks. The customer did not observe any deviations in the readings for axial length, keratometry, anterior chamber depth and white to white. Based on the successful daily calibration checks and the accurate readings confirmed by the customer, the manufacturer concluded that the iolmaster 500 was working within specification. The manufacturer evaluated the patient measurement and iol calculation printouts from the device. There are no lens constants available on the ulib webpage for the alcon arcysoft iq lens used. The manufacturer determined that the hcp manually entered the lens constant with a leading negative sign for the alcon arcysoft iq lens into the iolmaster 500 causing the refractive outcome. The lens constant used by the hcp is (among other constants) a2= -0. 204. Lenses similar to arcysoft iq typically have a leading positive sign for the a2 constant. The difference in the leading sign could lead to a significant variation in the refractive outcome. How to use the lens constants is described in the user manual. For example, on page 25 of user manual 000000-1692-983_swga_gb_280111, 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
[72175056]
The health care professional (hcp) reported the following: the os post refractive outcome after a cataract surgery with an intraocular lens (iol) implantation differed +6. 0 d from the calculated target refraction. The alcon acrysoft iq lens with a power of 7. 5 d was used. The hcp informed that a re-op was performed to exchange the lens. The same lens with a power of 18. 5 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 | 9615030-2017-00006 |
| MDR Report Key | 6473181 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-07 |
| Date of Report | 2017-04-07 |
| Date of Event | 2016-04-30 |
| Date Mfgr Received | 2017-03-08 |
| Device Manufacturer Date | 2012-01-12 |
| Date Added to Maude | 2017-04-07 |
| 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 |
| 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 | 2017-04-07 |
| Model Number | NA |
| Catalog Number | 000000-1794-857 |
| 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 | 2017-04-07 |