UNK_MONOFOCAL IOL
Received Jun 18, 2026 · Event occurred Feb 9, 2026
Report 3012236936-2026-000181 · MDR key 25553118
Device
Generic name
Intraocular Lens
Manufacturer
Amo Puerto Rico Mfg. Inc.Model number
UNKNOWNCatalog number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Visual Disturbances
- Halo
Narrative
Additional Manufacturer Narrative
. SECTION D6A: IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED.. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/ REPLACED IN THE INITIAL SURGERY. SECTION E1: INITIAL REPORTER: ADDRESS: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: INITIAL REPORTER: TELEPHONE NUMBER: (B)(6). SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED. ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT AFTER INSERTION OF AN UNKNOWN TECNIS LENS THE PATIENT EXPERIENCED DYSPHOTOPSIA, HALOS, AND GLARE. CONSEQUENTLY THE LENS WAS EXPLANTED DURING A SECONDARY PROCEDURE AND REPLACED WITH ANOTHER MODEL NON PRELOADED AR40 LENS. NO FURTHER INFORMATION WAS PROVIDED.