UNK_IFS_FEMTOSECOND LASER

Additional Manufacturer Narrative

SECTIONS A2: FORTY-TWO EYES FROM 21 PATIENTS (MEAN AGE: 26 ± 4 YEARS). SECTION A3: 11 MALES, 10 FEMALES. SECTIONS A4, A5 AND A6: NOT PROVIDED. SECTION B3 - DATE OF EVENT: EXACT DATE NOT PROVIDED. ARTICLE ACCEPTANCE DATE IS JUNE 18TH, 2026. SECTION D4 - MODEL NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - CATALOG NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - SERIAL NUMBER: UNKNOWN/NOT PROVIDED. SECTION D4 - EXPIRATION DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - UDI NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A - IMPLANT DATE: NOT APPLICABLE. THE DEVICE IS NOT AN IMPLANTABLE DEVICE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE. THE DEVICE IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. SECTION H3: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4 -DEVICE MANUFACTURE DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION H6 -HEALTH EFFECT - MEDICAL DEVICE PROBLEM CODE: 3191 AND COMPONENT CODE: 4756: DC-UNSPECIFIED/OTHER W/ PATIENT INVOLVEMENT. CITATION: HIEDA O, YAMAMURA K, WAKIMASU K, NAKAMURA Y, TANAKA S, KINOSHITA S. PROSPECTIVE, RANDOMIZED COMPARISON OF AXIAL ELONGATION AFTER LASIK VERSUS SOFT CONTACT LENS WEAR IN THE CONTRALATERAL EYE. OPHTHALMOL SCI. 2025 OCT 9;6(1):100956. DOI: 10.1016/J.XOPS.2025.100956. PMID: 41693807; PMCID: PMC12902135. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Description of Event or Problem

THE FOLLOWING ARTICLE WAS RECEIVED BASED OF A LITERATURE REVIEW: ARTICLE: PROSPECTIVE, RANDOMIZED COMPARISON OF AXIAL ELONGATION FOLLOWING LASIK VERSUS SOFT CONTACT LENS WEAR IN THE CONTRALATERAL EYE. A PROSPECTIVE, RANDOMIZED-CONTROLLED WITHIN-PERSON CLINICAL TRIAL WAS DONE TO EVALUATE WHETHER LASIK INDUCES AXIAL ELONGATION COMPARABLE TO OR LESS THAN THAT OBSERVED WITH CONTINUED SOFT CONTACT LENS (SCL) WEAR IN MYOPIC EYES. A TOTAL OF 42 EYES OF 21 PATIENTS WITH MYOPIA OR COMPOUND MYOPIC ASTIGMATISM WERE RANDOMIZED, WITH EACH PARTICIPANT UNDERGOING WAVEFRONT-GUIDED (WFG) LASIK IN ONE RANDOMLY ASSIGNED EYE WHILE THE CONTRALATERAL EYE CONTINUED SCL WEAR (21 EYES OF 21 PATIENTS UNDERWENT SURGERY). WFG-LASIK SURGERY WAS PERFORMED USING THE IFS ADVANCED FEMTOSECOND LASER, THE IDESIGN REFRACTIVE STUDIO WAVEFRONT ABERROMETER, AND THE STAR S4 IR EXCIMER LASER (JOHNSON & JOHNSON VISION). IT WAS REPORTED THAT COMPLICATIONS OBSERVED DURING FOLLOW-UP INCLUDED DRY EYE IN 1 LASIK-TREATED EYE AT 1 WEEK POSTOPERATIVELY (N=1 EYE), DIFFUSE LAMELLAR KERATITIS (DLK) IN LASIK EYES AT 1 WEEK AND 1 MONTH POSTOPERATIVELY (N=UNSPECIFIED NUMBER), AND ALLERGIC CONJUNCTIVITIS IN 1 LASIK EYE AT 1 YEAR POSTOPERATIVELY (N=1 EYE). AT THE 30-MONTH POSTOP, IT WAS REPORTED THAT THE OPERATED EYES DEMONSTRATED A TOTAL HIGHER-ORDER ABERRATION (HOA) OF 0.57 M, COMA-LIKE ABERRATION OF 0.38 M, SPHERICAL-LIKE ABERRATION OF 0.40 M, AND SPHERICAL ABERRATION OF 0.34 M. AT 4 MONTHS POST-LASIK, 1 EYE UNDERWENT ENHANCEMENT WITH AN ADDITIONAL 20.4 M OF CORNEAL ABLATION. A COPY OF THE ARTICLE IS ATTACHED TO THIS REPORT. NOTE: A SEPARATE REPORT WILL BE SUBMITTED FOR EACH REPORTED DEVICE.