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 2016-07-03 for IOLMASTER 700 000000-1932-169 manufactured by Carl Zeiss Meditec Ag (jena).
[48711889]
Narrative: a zeiss clinical application specialist (cas) evaluated the customer's workflow and the patient measurement and calculation printouts. The cas determined that the hcp entered lens constants for the alcon sn6at, which were different to the respective lens constants listed on the manufacturer recommended (b)(4) webpage. The source of the lens constants used is unknown. The cas demonstrated that the lens constants from the (b)(4) database would have led to the desired result and retrained the hcp. How to use the iolmaster 700 for iol calculation and how to use the lens constants is described in the user manual. For instance on page 53 of user manual 00000-1932-169 it is stated "the iol calculation is valid only if the biometric measurement was correct, an appropriate iol calculation formula was selected and the iol constants were optimized for the specific application". A warning message is given on page 76 with "constants subject to the lens type must be defined and entered prior to using the iolmaster 700. " and with "the constants should thus be subjected to regular review and refinement. " the device manufacture date for iolm 700 s/n (b)(4) is 12/2015 and for iolm 700 s/n (b)(4) it is 05/2016. The manufacturer received different information from the customer, which instrument was involved in the incident.
Patient Sequence No: 1, Text Type: N, H10
[48711890]
This is case two of two reported cases from same customer site. The health care professional (hcp) reported that the post refractive outcome after a cataract surgery using an alcon sn6at intraocular lens (iol) implantation differed by 2 diopters from the target refraction. It was further reported that lasik surgery to improve the visual acuity is planned. No further information regarding the patient and incident could be obtained. The hcp used the iolmaster 700 for the biometry measurements and iol calculations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2016-00008 |
| MDR Report Key | 5767743 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-07-03 |
| Date of Report | 2016-06-03 |
| Date Mfgr Received | 2016-06-03 |
| Device Manufacturer Date | 2015-12-01 |
| Date Added to Maude | 2016-07-03 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IOLMASTER 700 |
| Generic Name | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED, PRODUCT CODE: HJO |
| Product Code | HJO |
| Date Received | 2016-07-03 |
| Model Number | NA |
| Catalog Number | 000000-1932-169 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2016-07-03 |