Intraocular Lens

Device Code: 4299

Product Code(s): HQL

Device Classification Information

• Device Type ID: 4299
• Device Name: Intraocular Lens
• Regulation Description: Intraocular Lens.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED); Intraocular And Corneal Implants Devices Branch (ICIB)
• Submission Type: PMA
• CFR Regulation Number: 886.3600 [🔎]
• FDA Device Classification: Class 3 Medical Device
• Product Code: HQL
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 10-48 ISO 11979-5 Second Edition 2006-06-01
  Ophthalmic Implants - Intraocular Lenses - Part 5: Biocompatibility
• 10-63 ISO TR 22979 First Edition 2006-02-01
  Ophthalmic Implants - Intraocular Lenses - Guidance On Assessment Of The Need For Clinical Investigation Of Intraocular Lens Design Modifications
• 10-66 ISO 10936-2 Second Edition 2010-01-15
  Optics And Photonics - Operation Microscopes - Part 2: Light Hazard From Operation Microscopes Used In Ocular Surgery
• 10-72 ISO 15004-1 First Edition 2006-06-01
  Ophthalmic Instruments - Fundamental Requirements And Test Methods - Part 1: General Requirements Applicable To All Ophthalmic Instruments
• 10-78 ISO 11979-3 Third Edition 2012-12-01
  Ophthalmic Implants - Intraocular Lenses - Part 3: Mechanical Properties And Test Methods
• 10-79 ISO 11979-1 Third Edition 2012-09-15
  Ophthalmic Implants - Intraocular Lenses - Part 1: Vocabulary
• 10-89 ANSI Z80.7-2013 (R2018)
  American National Standard For Ophthalmic Optics - Intraocular Lenses
• 10-95 ISO 11979-6 Third Edition 2014-10-01
  Ophthalmic Implants - Intraocular Lenses - Part 6: Shelf-life And Transport Stability Testing
• 10-98 ISO 11979-2 Second Edition 2014-08-15
  Ophthalmic Implants - Intraocular Lenses - Part 2: Optical Properties And Test Methods
• 10-105 ISO 11979-8 Third Edition 2017-04
  Ophthalmic Implants - Intraocular Lenses - Part 8: Fundamental Requirements

Total Product Life Cycle

• Device Type ID: 4299
• Device: Intraocular Lens
• Product Code: HQL
• FDA Device Classification: Class 3 Medical Device
• Regulation Description: Intraocular Lens.
• CFR Regulation Number: 886.3600 [🔎]

Device Problems
Adverse Event Without Identified Device Or Use Problem	2704
Packaging Problem	2254
Leak / Splash	2220
IOL (Intraocular Lens) Implant	1201
Break	739
Appropriate Term/Code Not Available	655
Device Contamination With Chemical Or Other Material	506
Scratched Material	377
Torn Material	370
Device Operates Differently Than Expected	339
Material Opacification	324
Unintended Movement	305
Crack	283
Sticking	255
Difficult Or Delayed Positioning	231
Positioning Failure	208
Inadequacy Of Device Shape And/or Size	180
Malposition Of Device	145
Bent	138
Device Dislodged Or Dislocated	126
Difficult To Fold Or Unfold	124
Failure To Unfold Or Unwrap	105
Insufficient Information	93
Haptic	93
Detachment Of Device Component	92
Use Of Device Problem	84
No Apparent Adverse Event	81
Material Deformation	77
Mechanical Jam	71
Material Twisted / Bent	64
Split	59
Physical Resistance / Sticking	57
Fracture	54
Contamination / Decontamination Problem	52
Material Split, Cut Or Torn	48
Premature Activation	47
Entrapment Of Device	46
Material Integrity Problem	45
Failure To Fold	42
Device Handling Problem	41
Defective Device	40
Activation, Positioning Or Separation Problem	40
Positioning Problem	38
Device Damaged By Another Device	38
Failure To Advance	36
Calcified	36
Detachment Of Device Or Device Component	35
Separation Problem	33
Failure To Eject	33
Optical Problem	31
Difficult To Advance	29
Material Distortion	28
Contamination During Use	26
Inadequate Instructions For Healthcare Professional	25
Kinked	24
Difficult To Insert	23
Device Markings / Labelling Problem	23
Device Damaged Prior To Use	20
Migration Or Expulsion Of Device	20
Injection System	19
Difficult To Position	18
Patient-Device Incompatibility	17
Lenses	17
Deformation Due To Compressive Stress	17
Inaccurate Delivery	14
Dent In Material	14
Manufacturing, Packaging Or Shipping Problem	13
Improper Or Incorrect Procedure Or Method	13
Delivery System Failure	12
Mechanical Problem	11
Optical Decentration	11
Failure To Deliver	11
Sediment, Precipitate Or Deposit In Device Or Device Ingredient	11
Wrinkled	10
Material Separation	10
Partial Blockage	9
Cut In Material	9
Product Quality Problem	9
Component Missing	9
Optical Discoloration	8
Material Too Rigid Or Stiff	8
Folded	8
Plunger	8
Material Rupture	7
Physical Resistance	7
Material Discolored	7
Device Abrasion From Instrument Or Another Object	7
Material Frayed	7
Invalid Sensing	7
Delivered As Unsterile Product	6
Incorrect Measurement	6
Device Packaging Compromised	6
Material Protrusion / Extrusion	5
Unsealed Device Packaging	5
Hole In Material	5
Material Fragmentation	4
Device Issue	4
Sharp Edges	4
Unintended Ejection	4
Unexpected Therapeutic Results	4
Total Device Problems	15894

Recalls
Manufacturer		Recall Class	Date Posted
1	AMO Puerto Rico Manufacturing, Inc.	II	Aug-26-2014
2	AMO Puerto Rico Manufacturing, Inc.	II	Mar-03-2014
3	Aaren Scientific, Incorporated	II	Mar-20-2015
4	Abbott Medical Optics Inc. (AMO)	II	Sep-21-2016
5	Alcon Research, Ltd.	II	Sep-01-2016
6	Alcon Research, Ltd.	I	Nov-25-2015
7	Alcon Research, Ltd.	I	Aug-07-2015
8	Bausch & Lomb Surgical, Inc.	II	Dec-18-2018
9	Bausch & Lomb Surgical, Inc.	II	Jul-20-2015
10	Bausch & Lomb Surgical, Inc.	II	Feb-20-2014
11	Johnson & Johnson Surgical Vision Inc	II	Nov-14-2018
12	Rayner Intraocular Lenses Limited	II	Sep-28-2018
13	Tekia, Inc.	II	Nov-06-2015

TPLC Last Update: 2019-04-02 20:46:35