Incidence of Removal or Replacement of Copolymer Phakic IOLs Due to Inadequate Vault or Cataract in Eyes Using FDA Product Labeling
Narrative Responses:
Purpose
To present the incidence of the removal and or replacement of copolymer phakic IOLS due to inadequate vault or cataract extraction for secondary anterior subcapsular cataract in eyes when selecting patients based on FDA product labelling.
Methods
Using electronic medical records, a retrospective harvest of all eyes having undergone copolymer phakic IOL implantation (STAAR Vision ICL) in patients 21-45 years of age at time of surgery with anterior chamber depth of equal or greater than 3.0mm. No “off label” eyes were included in the analysis of the incidence of improper vault or secondary cataract requiring surgery. All eyes were operated by one surgeon.
Results
Of 1801 consecutive phakic IOL eyes, 13 (0.7%) underwent secondary surgery of removal and replacement of the phakic IOL due to improper vaulting. Low vault was the most common cause of secondary surgery. Ten eyes (0.6%) underwent cataract extraction and IOL surgery due to ICL induced anterior subcapsular cataract. Overall, 23 (1.3%) eyes underwent secondary surgery for inadequate vault or cataract. All eyes had good visual outcomes after secondary surgery.
Conclusion
The implantation of the copolymer phakic IOL remains a safe and effective refractive surgical option.