(86 days)
The Easy-Load Lens Delivery System is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the Easy-Load Lens Delivery System in their approved labeling.
The Easy-Load Lens Delivery System is used for folding and delivering a Bausch + Lomb three-piece silicone IOL into the eye. An IOL is placed into the loading area and the drawer is closed. This compresses the IOL. The plunger is advanced until it stops at a detent position. The distal end is filled with viscoelastic or balanced salt solution and placed through an incision into the eye. The haptic puller is used to place the leading haptic in the correct loading position. Once the tip is in the eye, the plunger is advanced until the lens is fully expressed into the capsular bag.
This document describes the premarket notification for the "Easy-Load Lens Delivery System" (Model EZ-24). It's an intraocular lens guide used for folding and injecting intraocular lenses.
Here's the information regarding the acceptance criteria and study, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | TEST | Acceptance Criteria | RESULTS |
|---|---|---|---|
| Function Performance | (Before and after insertion) IOL surface & bulk homogeneity | Free from surface and bulk defects and all edges should appear smooth when viewed at 10X magnification | Pass |
| (Before and after insertion) IOL lens power | The diopter power of the lenses shall be within the allowed tolerance | Pass | |
| (Before and after insertion) IOL image quality | The image quality of the lenses shall meet or exceed the minimum resolution group element of the Air Force target specified in the protocol. | Pass | |
| (Before and after insertion) IOL dimensions | The lenses must meet the dimensional requirements specified in the protocol. | Pass | |
| IOL delivery outcome | The IOLs do not flip over upon delivery; The IOL must exit inserter upon completion of delivery; No cosmetic defects to the IOL's haptic from folding and/or delivery | Pass | |
| Damage to insertion device | No damage to the insertion device due to lens delivery | Pass | |
| Lubricant transfer study | No detectable transfer | Pass | |
| Particle study | Comparable to or lower than control | Pass | |
| Sterilization verification | Comparative Resistance Performance Determination | For a given exposure time the average recovery of viable test organisms from biological indicators placed within the barrel of either the EZ-24 or the EZ-28 shall differ by no more than one logarithm of the average of the values determined for both inserters. Alternatively, the average recovery of viable test organisms from biological indicators placed within the barrel of the EZ-24 may be less than the average recovery of viable test organisms from biological indicators placed within the barrel of the EZ-28 inserters | Pass |
| EO transfer test | $\le$ 0.5μg EO per IOL | Pass | |
| Endotoxin test | $ |
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.