SENSAR IOL

Description of Event or Problem

THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: REFRACTIVE, VISUAL, AND SAFETY OUTCOMES OF THREE SURGICAL TECHNIQUES FOR APHAKIA CORRECTION. A MULTISURGEON RETROSPECTIVE CASE SERIES WAS DONE TO COMPARE REFRACTIVE, VISUAL, AND SAFETY OUTCOMES OF 3 METHODS FOR SURGICAL CORRECTION OF APHAKIA: ANTERIOR CHAMBER INTRAOCULAR LENS (AC IOL), INTRASCLERAL HAPTIC FIXATION INTRAOCULAR LENS (ISHF-IOL), AND GORE-TEX SUTURE FIXATION OF MODIFIED EYELET TORIC INTRAOCULAR LENS (GSF-MET IOL). A TOTAL OF 357 EYES UNDERWENT APHAKIA CORRECTION SURGERY WHICH INCLUDED AC IOL IMPLANTATION IN 52 EYES, GSF-MET IOL IMPLANTATION IN 62 EYES, AND ISHF-IOL IMPLANTATION IN 243 EYES. WITHIN THE ISHF-IOL GROUP, CT LUCIA 602 WAS IMPLANTED IN 154 EYES AND SENSAR AR40 (JOHNSON & JOHNSON VISION) WAS IMPLANTED IN 89 EYES. BOTH STUDIED IOL MODELS USED FOR SCLERAL FIXATION SURGERY WERE REPORTED AS OFF-LABEL USE. POSTOPERATIVE COMPLICATIONS ASSOCIATED WITH THE SENSAR AR40 INCLUDED CYSTOID MACULAR EDEMA (8 EYES) AND RETURN TO THE OPERATING ROOM (2 EYES) DUE TO IOL-RELATED ISSUES, INCLUDING DISLOCATION, OPTIC-HAPTIC DISLODGEMENT, AND/OR IOL TILTING. NO FURTHER INTERVENTIONS WERE REPORTED. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

Additional Manufacturer Narrative

SECTION A2: AGE ON DATE OF SURGERY (Y): MEAN (SD): 66.36 (16.04). SECTION A3A: SEX, N (%): FEMALE: 36 (40.45), MALE: 53 (59.55). SECTION A4 & A5: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION A6: RACE, N (%): ASIAN: 1 (1.12), BLACK: 6 (6.74, HISPANIC: 1 (1.12), NATIVE AMERICAN: 4 (4.49), OTHER/UNKNOWN: 19 (21.35), WHITE: 58 (65.17). SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED; ARTICLE ACCEPTANCE DATE IS JUNE 6, 2025. SECTION D4: MODEL NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. THE BEST ESTIMATE IS THAT THE LENS WAS A AR40 MODEL. SECTION D4: CATALOG NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. THE BEST ESTIMATE IS THAT IT WAS A AR40 LENS. SECTION D4: SERIAL NUMBER: UNKNOWN, AS INFORMATION WAS NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A: IF IMPLANTED; GIVE DATE: UNKNOWN/INFORMATION NOT PROVIDED. SECTION D6B: IF EXPLANTED; GIVE DATE: UNKNOWN/INFORMATION NOT PROVIDED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER FOR THIS DEVICE IS UNKNOWN/NOT PROVIDED; THEREFORE, NO FURTHER PRODUCT INVESTIGATION CAN BE PERFORMED. SHOULD ANY FURTHER RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. CITATION: REDDEN LD, HOANG D, RANGU N, MURPHY DA, DING K, WENDELSTEIN J, RIAZ KM. REFRACTIVE, VISUAL, AND SAFETY OUTCOMES OF THREE SURGICAL TECHNIQUES FOR APHAKIA CORRECTION. J CATARACT REFRACT SURG. 2025 NOV 1;51(11):995-1003. DOI: 10.1097/J.JCRS.0000000000001723. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, THE INFORMATION HAS NOT BEEN PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.