MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-19 for CONSTELLATION VISION SYSTEM ASKU manufactured by Alcon Research, Llc - Irvine Technology Center.
[184069788]
Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184069789]
A surgeon reported there was a loss of infusion pressure during a procedure. The patient experienced an eye collapse and retinal tear. Additional information has been requested and received. Additional information has been received from the surgeon which indicated the patient had proliferative diabetic retinopathy (pdr) with retinal traction, and was under going a vitrectomy procedure with laser treatment for this issue. The surgery was going as planned with the expected issues of mild corneal haze, blood stuck to back surface of lens, epi retinal membrane (erm) and retinal tractions. After removal of the tractions and peeling of the erm the retina was observed to be completely flat with no obvious breaks. The patient felt some discomfort during the indentation process of the procedure so additional anesthesia was administered subtenons. The laser portion of the procedure was performed under air. The surgeon went back to fluid/air exchange (fax) and the eye suddenly collapsed. A break in the retina was observed 180 degrees opposite the inferotemporal infusion line. A small air bubble had escaped subretinally as well. A rrhegmategenous retinal detachment was noted. The break was sealed using cryotherapy and gas.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-2020-00249 |
| MDR Report Key | 9853105 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-19 |
| 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. JONATHAN SCHLECH |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514979 |
| Manufacturer G1 | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER |
| Manufacturer Street | 15800 ALTON PARKWAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONSTELLATION VISION SYSTEM |
| Generic Name | UNIT, PHACOFRAGMENTATION |
| Product Code | HQC |
| Date Received | 2020-03-19 |
| Model Number | ASKU |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER |
| Manufacturer Address | 15800 ALTON PARKWAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-19 |