Appendix

Appendix – Tables with Additional Details

Table 1A – Percent Adverse Events Data Withheld by Manufacturers

Manufacturer	PMA	Approval Date	Data Source	FU (mos)	Spectacles May be Needed
Kremer LASIK	P970005	2/13/98	Table 9 – Cohort 2	12	79.9
Kremer LASIK	P970005	2/13/98	9b – Cohort 1	12	39.7
VISX LASIK	P990010	7/22/99	TABLE 19	3	62.1
Nidek EC–5000	P970053S2	4/14/00	Table 16	12	41.5
LADARVision	P970043S5	5/9/00	Table 16	6	57.9
VISX Star S2, S3	P900016S12	4/27/01	Table 14	6	29.4
LaserSight	P980008S5	9/28/01	Table 15 – astigmatism	6	88.2
LaserSight	P980008S5	9/28/01	Table 15 – w astigmatism	6	73
VISX	P930016S14	11/6/01	Table 15	6	4.3
LADARVision 4000	P970043S10	10/18/02	Table 18	6	68.1
VISX Star S4	P930016S16b	5/23/03	Table 11b	6	22.3
Allegretto Wave	P020050	10/7/03	Table 26 Study Cohort	3	7.6
Allegretto Wave	P030008	10/10/03	Table 16	6	10.3
LADARVision 4000	P970043S15	6/29/04	Table 22	3	29.9
VISX Star S4	P930016S17c	12/14/04	Table 3-37	6	1.1
VISX WaveScan	P930016S20c	3/17/05	Table 3-26	6	7
VISX Star S4	P930016S21	8/30/05	Table 3-22	6	41.8
Allegretto Wave	P930008S4	4/19/06	Table 15	6	12.3
LADARVision 4000	P970043S20	5/1/06	Table 30	6	20.2
LADARVision 4000 & 6000	P970043S22	5/2/06	Table 30	6	0
Allegretto Wave	P020050S4	7/26/06	Table 26 Study Cohort	3	4.2
Allegretto Wave	P020050S4	7/26/06	Table 26 Control Group	3	6.4
MEL-80	P060004	8/11/06	Table 13	6	2.2
Nidek EC-5000	P970053S9	10/11/06	Table 21	12	5.2
VISX Star Wave	P930016S25	7/11/07	Table 43	12	9.4
Sum					724
n					25
Mean					29.7

 

 

Table 2A – Percent Patients That May Need Spectacles 6-12 Months After LASIK

Manufacturer	PMA	Approval Date	Data Source	FU (mos)	Spectacles May be Needed
Kremer LASIK	P970005	2/13/98	Table 2a – Cohort 1	12	32.7
Kremer LASIK	P970005	2/13/98	Table 2a – Cohort2	12	39.9
VISX Star S2	P990010	7/22/99	Table 11	6	54.1
Nidek EC-5000	P970053S2	4/14/00	Table 11	12	48.9
LADARVision	P970043S5	5/9/00	Table 10	9	67.3
LADARVision	P970043S5	5/9/00	Table 11	9	43.4
VISX Star S2,S3	P930016S12	4/27/01	Table 5	6	48.1
LaserSight	P980008S5	9/28/01	Table 6	12	51.8
VISX Star S2,S3	P930016S14	11/6/01	Table 5	6	61.8
LADARVision 4000	P970043S10	10/18/02	Table 10	6	17.3
VISX Star S4	P930016S16c	5/23/03	Table 3.5	12	27.9
Allegretto Wave	P020050	10/7/03	Table 5	12	87.4
Allegretto Wave	P030008	10/10/03	Table 5	12	67.5
LADARVision 4000	P970043S15	6/29/04	Table 8	6	22.9
VISX Star S4	P930016S17	12/14/04	Table 7a	6	61.8
VISX Star WaveScan	P930016S20c	3/17/05	Table 3.6	12	27
VISX Star WaveScan	P930016S21c	8/30/05	Table 3-8	12	28.1
Allegretto Wave	P930008S4	4/19/06	Table 5	6	69.4
LADARVision 4000	P970043S20	5/1/06	Table 13	9	9.4
LADARVision 4000 & 6000	P970043S22	5/2/06	Table 11 *Study Cohort	9	20.4
Alllegretto Wave	P020050S4	7/26/06	Table 30	6	40.3
Alllegretto Wave	P020050S4	7/26/06	Table 11 *Control Cohort	6	42.9
MEL-80	P060004c	8/11/06	Table 14	6	33.4
Nidek EC-5000	P970053S9	10/11/06	Table 12	12	1.1
MEL-80	P060004b	8/11/06	Table 5	6	92.7
VISX Star Wave	P930016S25	7/11/07	Table 15	12	12.7
Sum					1110.2
N					26
Mean					42.7

 

 

Table 3A – Mean Percent Vision Adverse Events After LASIK Data From PMA Documents Identified in Table 1A Data Used in Figures 2 - 7

Adverse Events	Months After LASIK
	1	3	6	12
Vision fluctuates in normal light	29.2	12.4	15.2	24
Vision fluctuates in dim light	29.8	18.1	22.2	31.8
Redness	22.7	5.4	7.6	19.3
Vision fluctuates in bright light	33	9.5	13.4	18.6
Blurry vision	15.8	5.6	13.5	14.6
Gritty feeling	23.7	8.8	9.3	14.4
Vision fluctuates overall	55.6	15.0	17.8	14.4
Burning sensation	15.5	7.3	6.2	12
Light sensitivity	36.2	12.0	15.3	7.8
Glare	12.8	8.9	11.6	5.7
Night driving problems	24.3	9	10.9	5.6
Excessive tearing	4.9	1.6	2.5	5.4
Ghosts	21.4	5.1	7.0	5.3
Dryness	54.2	22.0	20.6	5.0
Halos	31.6	14.0	14.1	4.8
Double vision	6.2	4.2	4.4	3.5
Headaches	10.8	5.0	5.3	3.0
Foreign body sensation	1.4	0.5	2.2	0.8
Pain	2.4	3.0	2.3	0.7