3M¿ TRANSPORE¿ SURGICAL TAPE
Received Jul 20, 2026 · Event occurred Feb 3, 2026
Report 2110898-2026-00055 · MDR key 25879121
Device
Generic name
Tape And Bandage, Adhesive
Manufacturer
3m CompanyModel number
1527-1Catalog number
1527-1
Lot number
345HWD
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Corneal Abrasion
Narrative
Description of Event or Problem
3M¿ TRANSPORE¿ SURGICAL TAPE WAS APPLIED FOR CLOSURE OF THE EYES DURING A MAXILLOFACIAL OPERATION. SEVERE EYE PAIN IN BOTH EYES WAS EXPERIENCED UPON AWAKENING FROM ANESTHESIA, AND A PAIN MEDICATION WAS PRESCRIBED. THE PATIENT WAS REFERRED TO AN OPHTHALMOLOGIST AND SEVERE CORNEAL ABRASION WAS OBSERVED IN BOTH EYES. THE OPHTHALMOLOGIST PROVIDED TREATMENT FOR BOTH EYES WHICH INCLUDED TOBRADEX, HYLOGEL EYE DROPS, ILEVRO DROPS AND SUSTAIN GEL DROPS (QID), EACH ADMINISTERED FIFTEEN MINUTES APART FOR THREE DAYS. A CORNEAL CAP WAS ALSO PLACED.
Additional Manufacturer Narrative
NO PRODUCT SAMPLES HAVE BEEN RECEIVED FOR ANALYSIS; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. USE OF SURGICAL TAPE FOR EYELID CLOSURE IS A COMMON CLINICAL PRACTICE; HOWEVER, OCULAR INJURY IS A KNOWN PROCEDURAL RISK AND MAY RESULT FROM MULTIPLE CONTRIBUTING FACTORS. THESE MAY INCLUDE INCOMPLETE EYELID CLOSURE, UNINTENDED EXPOSURE OF THE CORNEA, POTENTIAL CONTACT OF ADHESIVE WITH THE OCULAR SURFACE, PATIENT-SPECIFIC SUSCEPTIBILITY, AND INTRAOPERATIVE CONDITIONS. TRANSPORE SURGICAL TAPE IS NOT INTENDED FOR DIRECT OCULAR CONTACT, BUT FOR EXTERNAL USE ON INTACT SKIN.