Outbreak of Subacute-Onset Toxic Anterior Segment Syndrome Associated with Single-Piece Acrylic Intraocular Lenses.

PURPOSE

To report the results of a clinical investigation after an outbreak of subacute-onset toxic anterior segment syndrome (TASS) after implantation of single-piece acrylic intraocular lenses (IOLs), which then were recalled voluntarily from the market.

DESIGN

Retrospective, multicenter, observational case series.

PARTICIPANTS

Cases reported to the manufacturer from January 2015 through March 2016 of unusual ocular inflammation after cataract surgery using AcrySof ReSTOR, ReSTOR toric, or AcrySof IQ toric SN6AT6-9 IOLs (Alcon Laboratories, Inc., Fort Worth, TX).

METHODS

The independent investigation committee, not Alcon, directly requested the surgeons for data on 304 eyes from 184 facilities.

RESULTS

Consent for data collection was obtained for 201 eyes from 130 facilities. By excluding cases with infectious endophthalmitis and inconclusive cases, the investigation committee identified 147 cases of subacute-onset TASS. AcrySof ReSTOR or ReSTOR toric IOLs and AcrySof IQ toric SN6AT6-9 IOLs were implanted in 94 eyes (63.9%) and 53 eyes (36.1%), respectively. The mean onset time was 13.1±16.4 days after surgery (range, 1-88 days), with 84 eyes (57.1%) demonstrating symptoms within 7 days after surgery. Typical clinical symptoms were mild to moderate exacerbation of inflammation in the anterior chamber after an uneventful clinical course for a few days after surgery. One hundred four eyes (70.7%) were treated with medication alone, and 43 eyes (29.3%) underwent surgery, including irrigation of the anterior chamber, vitrectomy, and removal of the IOL. The mean best-corrected visual acuity (BCVA) at the final visit (-0.012±0.175 logarithm of the minimum angle of resolution [logMAR]) was significantly better than the BCVA at the onset of TASS (0.158±0.351 logMAR) and did not differ from that before inflammation developed (-0.004±0.162 logMAR). Overall treatment outcomes were favorable.

CONCLUSIONS

A large-scale outbreak of subacute-onset TASS developed after implantation of a specific model of IOL.