Report of the Eye Bank Association of America Medical Review Subcommittee on Adverse Reactions Reported From 2007 to 2014.

PURPOSE: To investigate the incidence of adverse reactions after corneal transplantation, reported to the Eye Bank Association of America.
METHODS: Incidence of adverse reactions from January 1, 2007, to December 31, 2014, was analyzed.
RESULTS: Of the 354,930 transplants performed in the United States, adverse reactions were reported in 494 cases (0.139%). Primary graft failure (PGF) predominated (n = 319; 0.09%) followed by endophthalmitis (n = 99; 0.028%) and keratitis (n = 66; 0.019%). The procedure type predominantly associated with PGF was endothelial keratoplasty (EK) in 56% (n = 180; 11 per 10,000 grafts), followed by penetrating keratoplasty (PK) in 42% (n = 135; 6.9 per 10,000 grafts). The procedure type predominantly associated with endophthalmitis and keratitis was EK in 63% (n = 104; 6.3 per 10,000 grafts) followed by PK in 34% (n = 56; 2.8 per 10,000 grafts), anterior lamellar keratoplasty in 1% (n = 2; 2.7 per 10,000 grafts), and keratoprosthesis in 1% (n = 2; 12.4 per 10,000 grafts). Although the incidence of PGF and endophthalmitis between PK and EK was noteworthy, the difference was not statistically significant (P = 0.098). Endophthalmitis-associated pathogens were isolated in 78% of cases: predominantly Candida species (65%), gram-positive organisms (33%), and gram-negative rods (2%). Keratitis-associated pathogens were isolated in 64% of cases: predominantly Candida species (81%), Herpes simplex virus (7%), gram-negative organisms (7%), and gram-positive organisms (5%).
CONCLUSIONS: PGF was the most commonly reported adverse reaction, disproportionately associated with EK. An increasingtrend in the rate of endophthalmitis and keratitis was observed, disproportionately associated with EK and Candida species.