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 2018-03-29 for KAMRA ACI 7000 76043 manufactured by Acufocus, Inc..
[103861265]
Patient Sequence No: 1, Text Type: N, H10
[103861266]
The reported information stated the inlay was explanted from the left eye of a (b)(6) female patient approximately 10 months postoperatively due to blurry vision at near and distance and difficulty adapting. Prior to the explant the patient was being treated for dry eye and hyperopic shift.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008401069-2018-00001 |
| MDR Report Key | 7382290 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-29 |
| Date of Report | 2018-03-29 |
| Date of Event | 2018-02-22 |
| Date Mfgr Received | 2018-03-02 |
| Device Manufacturer Date | 2015-05-01 |
| Date Added to Maude | 2018-03-29 |
| 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 |
| Reporter Occupation | MEDICAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS SANDRA SELVAGGI |
| Manufacturer Street | 32 DISCOVERY SUITE 200 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9495859511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KAMRA |
| Generic Name | CORNEAL INLAY |
| Product Code | LQE |
| Date Received | 2018-03-29 |
| Returned To Mfg | 2018-03-05 |
| Model Number | ACI 7000 |
| Catalog Number | 76043 |
| Lot Number | A557-0515 |
| Device Expiration Date | 2017-05-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACUFOCUS, INC. |
| Manufacturer Address | 32 DISCOVERY SUITE 200 IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-29 |