IOL Defects
NEW- ADVERSE INCIDENT NOTIFICATION FORM - IOL DEFECTS
1 **  Date of notification

Section A: Description of Adverse Event
1 Date of diagnosis of IOL defect Pick a Date
2 Date of IOL implantation Pick a Date   Estimated year
(If the exact date is not known, please enter 30/06/yyyy and tick the Estimated year checkbox)
3 **  Type of incident
IOL Opacification Fine deposits on optic Early cataract formation subsequent to phakic IOL implantation Failure of IOL injector
Crack on optic Fracture or detachment of haptic(s) Incorrect labeling of IOL, including IOL power Others, specify: 
Lines on optic
4 Patient characteristics
a **  Age of patient at implantation:
b **  Current age
c **  Gender
Male Female Missing    
d **  Ocular co-morbidity
Glaucoma Uveitis Diabetic retinopathy
Others, specify: 
None Ocular co-morbidity
e **  Systemic co-morbidity
Diabetes mellitus Renal failure Hypercalcemia
Others, specify:
None Systemic co-morbidity
f **  Previous ocular surgery
(besides cataract surgery)
Glaucoma surgery Vitreoretinal surgery
Others, specify:
None Previous ocular surgery
Section B: Action Taken
1 **  Action taken
None
Monitoring
Explantation of IOL
a **  Date of explantation Pick a Date
b **  Replaced with new IOL?
Yes No Not Available Missing
c **  Decrease in best corrected visual acuity
Decrease in best corrected visual acuity IOL dislocation
Significant halos / glare / starbursts IOL opacification
Significant irregular astigmatism induced IOL defect
Diplopia, or other significant visual disturbances Others, specify:
Section C: Outcome of Incident
1 **  Outcome
Financial loss - Hospital or individual
(e.g. the need to buy new IOL and have another operation)		 Complaint from public
Distress to the patient Non-significant
Section D: Details of IOL
1 **  IOL company
Alcon Medennium Freedom IOL The Vision Membrane phakic IOL
Hoya Ophtec AMO The PRL Phakic Refractive Lens
ERILENS Oll Intracular Lenses Tekia Inc Eyeonics
Lenstec Corneal Staar GEL-MED International
Bausch & Lomb Zeiss Others, specify Not known
Missing            

Others, specify
2 **  IOL model
* Note: Please email to NED manager to request add IOL Brand if not found in the drop down list.
Email NED manager at mohamadazizsalowi@gmail.com.



3 IOL type
Foldable Non Foldable
Not known Missing
3ii IOL material
Acrylic hydrophobic Silicone Not known
Acrylic hydrophilic PMMA Missing
4 Lot No. / Serial No.
5 IOL Expired date Pick a Date
6 Distributor company
a Name
b Contact address
c Email
d Contact no.
H/P
Section E: Reporting Centre and Person
1 **  Reporting person's name
2 **  Position
Doctor Nurse Medical Assistant Others, specify
Missing            
Others, specify
3 **  Name of Facility
4 **  Email
5 **  Contact no
H/P
Image Verification
1 **  Image Verification
2 **  Type the characters you see in this image



Copyright ©2010 eClinReg | Powered by Altus Solutions Sdn. Bhd.
This application supports Microsoft Internet Explorer 7.0 and above and Mozilla Firefox 8.0 and above.