TECNIS SIMPLICITY DIB00 (REF DIB00U0195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 05050474731745), received between Sep 29, 2021 and May 5, 2026 — classified as 17 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Break” (31 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Material Fragmentation

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS MISSING A HAPTIC AFTER BEING FULLY IMPLANTED INTO A PATIENT¿S OPERATIVE EYE. THE PATIENT¿S STATUS IS UNKNOWN, AND THERE IS NO INFORMATION IF UNPLANNED SUTURES OR AN INCISION ENLARGEMENT WAS REQUIRED. THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED WITHOUT UNPLANNED VITRECTOMY AND DELAY IN PROCEDURE. THE PATIENT HAS BEEN REFERRED TO ANOTHER SURGEON FOR CONSIDERATION TO HAVE THE LENS REMOVED. DUE TO PRIVACY LEGISLATION, NO PATIENT INFORMATION WAS DISCLOSED, AND THE CUSTOMER DID NOT HAVE FURTHER DETAILS ABOUT THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089527 ↗
• MalfunctionApr 15, 2026Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00, IMPLANTED IN THE PATIENT¿S RIGHT EYE WAS NOTED TO BE CRACKED. THE LENS WAS REMOVED AND REPLACED WITH A NON¿JOHNSON & JOHNSON LENS USED AS A BACKUP. BALANCED SALT SOLUTION WAS USED WITH THE INJECTOR. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED, INCLUDING VITRECTOMY, INCISION ENLARGEMENT, SUTURES, OR MEDICATIONS BEYOND THE STANDARD OF CARE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24882443 ↗
• MalfunctionApr 9, 2026Break; Mechanical Jam

  IT WAS REPORTED THAT THE HAPTIC OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) BROKE, REMAINED IN THE LOADER, AND WOULD NOT ADVANCE. THERE WAS PATIENT CONTACT WITH THE DEVICE. THROUGH FOLLOW-UP, IT WAS CLARIFIED THAT THE TIP OF THE CARTRIDGE WAS NOT DAMAGED; HOWEVER, THE ENTIRE LENS BECAME STUCK IN THE LOADER, AND THE HAPTIC REMAINED ATTACHED WITHOUT DETACHING. THE EXTENT OF PATIENT CONTACT INVOLVED INSERTION OF THE LOADER INTO THE RIGHT EYE BY THE DOCTOR. THE LENS WAS NOT PARTIALLY OR FULLY INSERTED INTO THE EYE, AS IT BECAME STUCK IN THE LOADER AND WOULD NOT DELIVER, AND RESISTANCE WAS ENCOUNTERED DURING ATTEMPTED ADVANCEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACKUP INTRAOCULAR LENS OF THE SAME MODEL AND DIOPTER. NO PATIENT INJURY WAS REPORTED, AND NO UNPLANNED MEDICAL OR SURGICAL INTERVENTIONS, INCLUDING VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES, WERE REQUIRED. THE DEVICE WAS REPORTED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE PATIENT OUTCOME WAS REPORTED AS FINE. IT WAS INDICATED THAT AN OPHTHALMIC VISCOELASTIC DEVICE (OVD) WAS USED FOR CARTRIDGE LUBRICATION. THE LUBRICANT WAS INTRODUCED INTO THE CARTRIDGE THROUGH THE CANOPY, AND NO COMBINATION OF B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24837680 ↗
• MalfunctionMar 25, 2026Scratched Material

  IT WAS REPORTED THAT AFTER A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED IN A PATIENT'S LEFT EYE A SCRATCH WAS OBSERVED ON THE LENS. THE LENS WAS SUBSEQUENTLY EXPLANTED DURING THE SAME PROCEDURE. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24683759 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT A SINGLE PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A HAPTIC MALFUNCTION. THE EVENT WAS OBSERVED UPON OPENING THE PACKAGE. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681390 ↗
• MalfunctionMar 6, 2026Break

  IT WAS REPORTED THAT A SINGLE PIECE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS CRACKED. PATIENT CONTACT IS NOT KNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536914 ↗
• MalfunctionFeb 19, 2026Contamination

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON IDENTIFIED A FOREIGN MATERIAL ON THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). THE MATERIAL WAS SUCCESSFULLY REMOVED; HOWEVER, IT DISINTEGRATED DURING THE REMOVAL PROCESS AND COULD NOT BE PRESERVED FOR RETURN. THE LENS WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397795 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE FROM A PATIENT¿S RIGHT EYE BECAUSE OF PHOTOPSIA, WHICH PERSISTED FOR 3.5 MONTHS. THE ISSUE WAS NOTED DURING THE PATIENT'S SITE VISIT. IT IS UNKNOWN IF THE SYMPTOMS IMPACTED PATIENT'S DAILY ACTIVITIES. A NON-JOHNSON & JOHNSON LENS OF +18.75 DIOPTER WAS IMPLANTED. THE INCISION WAS ENLARGED, BUT NO UNPLANNED VITRECTOMY OR SUTURES WERE REQUIRED. IT IS UNKNOWN IF THERE WAS A DELAY IN PROCEDURE. IT IS UNKNOWN WHETHER THE PATIENT REQUIRED ADDITIONAL MEDICAL ATTENTION OR MEDICATION BEYOND THE STANDARD OF CARE; HOWEVER, THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 24104125 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD THE LEADING HAPTIC TWISTED AND UNUSUALLY CONFIGURATION. AS A RESULT, THE LENS WAS NOT IMPLANTED, AND A BACKUP LENS WAS USED. THERE WAS NO CONTACT WITH THE PATIENT¿S OPERATIVE EYE, NO PATIENT INVOLVEMENT, AND NO ADVERSE EFFECTS REPORTED. THE CUSTOMER PROVIDED ADDITIONAL INFORMATION CONFIRMING THAT THE HAPTIC WAS DAMAGED (TWISTED), WHILE THE CARTRIDGE TIP REMAINED UNDAMAGED, AND NO FORCE WAS APPLIED TO DELIVER THE LENS. IT WAS CONFIRMED THERE WAS NO PATIENT CONTACT. THE DAMAGE WAS NOT ATTRIBUTED TO USER ERROR, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP INTRAOCULAR LENS. THERE WAS NO PATIENT INJURY AND NO UNPLANNED MEDICAL OR SURGICAL INTERVENTIONS. THE CUSTOMER WAS ASKED TO PROVIDE ANY PHOTOS OR VIDEOS RELATED TO THE EVENT; HOWEVER, NONE WERE AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846561 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S RIGHT EYE MODEL DIB00 19.5 DIOPTER. THE PATIENT EXPERIENCED BLURRY VISION. THE VISION IN HER RIGHT IS ¿NOT GREAT¿. A WEEK LATER THE PATIENT HAD ANOTHER JNJ LENS IMPLANTED IN HER LEFT EYE. THE MODEL AND SERIAL NUMBER WERE NOT PROVIDED. IN HER LEFT EYE THE PATIENT EXPERIENCED BLURRY VISION, PAIN AND WHAT FELT LIKE GRIT IN HER EYE. REPORTEDLY, THE SURGEON SAID SHE MAY HAVE HAD A STROKE AND THAT MAY BE THE CAUSE OF HER BLURRY VISION. THE PATIENT SAID THAT HER NEUROLOGIST CONFIRMED SHE HAD NOT HAD A STROKE. SHE WENT TO A RETINA SPECIALIST TO HAVE HER LENS CLEANED DUE TO ¿GEL¿ IN HER EYE WHICH IS ATTRIBUTED TO HER AGE. SHE ALWAYS SAW LIKE A THUMP PRINT ON THE LENS, AFTER THE RETINA SPECIALIST DID THE ¿LENS CLEANING¿ THE PAIN WAS ALLEVIATED. HOWEVER, SHE CONTINUES TO EXPERIENCE BLURRY AND IS NOT ABLE TO SEE THE STREET SIGNS. THE PATIENT CONTINUES COMMUNICATION WITH HER DOCTOR. JOHNSON AND JOHNSON HAS PERFORMED SEVERAL FOLLOW-UPS BUT THE CUSTOMER HAS NOT RESPONDED. NO FURTHER INFORMATION WAS PROVIDED. NOTE, THIS REPORT IS FOR THE RIGHT EYE. MANUFACTURER REPORT NUMBER 3012236

  Patient problems: Blurred Vision

  MAUDE report 23774914 ↗
• MalfunctionDec 2, 2025Mechanical Jam; Ejection Problem; Mechanical Jam; Ejection Problem

  THE TRAILING HAPTIC OF THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS STUCK ON THE ADVANCEMENT ROD AND THE DOCTOR USED A SINSKEY HOOK TO DISLODGE THE LENS FROM THE INSERTER. THERE WAS NO RESISTANCE DURING IOL DEPLOYMENT, NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURES, NO VITRECTOMY, AND THE CASE WAS COMPLETED USING THE ORIGINAL LENS. PATIENT'S PROGNOSIS POST-PROCEDURE WAS REPORTED AS WILL LIKELY DO FINE. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694559 ↗
• MalfunctionNov 26, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FOUND DAMAGED DURING THE OPENING OF THE MANUFACTURER¿S BOX IN THE OPERATING ROOM. THERE WAS NO PATIENT CONTACT AND NO ADVERSE EVENT OCCURRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656812 ↗
• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO INFORMATION WAS PROVIDED REGARDING HOW THE LENS WAS DEFECTIVE. IT WAS INDICATED THAT THERE WAS NO PATIENT CONTACT, HOWEVER, IT WAS NOT CONFIRMED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A BACK-UP LENS. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594007 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER INSERTION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE SURGEON NOTICED THE CAPSULAR BAG CAME APART. THE LENS WAS REMOVED AND REPLACED WITH A 3-PIECE IOL. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 23501816 ↗
• InjuryNov 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO DISPLACED HAPTICS. THE ISSUE WAS IDENTIFIED DURING A POSTOPERATIVE EXAMINATION (GRADUAL ONSET). THE SECONDARY SURGICAL PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS, SUCH AS ENLARGEMENT OF INCISIONS OR NEED FOR VITRECTOMY. THE PATIENT HAS FULLY RECOVERED. IT WAS REPORTED THAT THE DIRECTION FOR USE WERE FOLLOWED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SURGEON ATTEMPTED TO TEASE THE HAPTIC FROM THE CAPSULE BUT IT GOT STUCK SO THE IOL WAS REMOVED. A CAPSULE TEAR WAS OBSERVED. IT IS UNKNOWN WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THE PROCEDURE WAS NOT COMPLETED; NO REPLACEMENT LENS WAS IMPLANTED AT THAT TIME, AND THE PLAN IS TO PERFORM THE YAMANE TECHNIQUE IN THE FUTURE. NO MEDICATIONS BEYOND THE STANDARD OF CARE WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459162 ↗
• MalfunctionOct 29, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING HANDLING, PRIOR TO INSERTION, THE PRELOADED MONOFOCAL INTRAOCULAR LENS (MODEL DIB00) ADVANCED TOO QUICKLY OUT OF INSERTER. THE CARTRIDGE TIP CAME INTO CONTACT WITH THE PATIENT'S RIGHT EYE; HOWEVER, THE LENS WAS NOT INSERTED. THERE WAS NO UNPLANNED INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY REQUIRED, AND NO DELAY IN THE PROCEDURE. THE ISSUE DID NOT PREVENT THE PATIENT TO PERFORM THEIR DAILY ACTIVITIES. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413776 ↗
• MalfunctionOct 21, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS PERMANENTLY BENT OUT OF THE CARTRIDGE. CONSEQUENTLY, THE USER WAS REQUIRED TO OPEN A NEW LENS. REPORTEDLY THERE WAS PATIENT CONTACT RELATED TO THIS INCIDENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23353762 ↗
• MalfunctionOct 16, 2025Crack; Mechanical Jam; Crack; Mechanical Jam

  THE CARTRIDGE TIP OF THE DIB00 MODEL INTRAOCULAR LENS (IOL) WAS BENT AND DID NOT LOAD PROPERLY; THERE WAS PATIENT CONTACT WITH THE CARTRIDGE TIP. THERE WAS NO INCISION ENLARGEMENT, NO PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY DURING THE PROCEDURE. A THIRD BACK-UP LENS WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23319300 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS, THE FEMALE PATIENT EXPERIENCED INTOLERABLE HALOS, GLARE, AND BLURRY VISION. CONSEQUENTLY, THE SURGEON SCHEDULED AN EXPLANT FOR THE RIGHT EYE. ADDITIONAL INFORMATION INDICATED THAT THE LENS WAS EXPLANTED DURING SECONDARY SURGERY AS SCHEDULED AND REPLACED WITH A NON-J&J LENS. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 23033483 ↗
• MalfunctionSep 4, 2025Scratched Material; Scratched Material

  THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) WAS SCRATCHED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22974536 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL LENS WAS EXPLANTED DUE TO VISUAL DISTURBANCES AND DIFFICULTIES IN ADAPTING TO IT. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH ANOTHER LENS OF THE SAME MODEL BUT WITH A HIGHER DIOPTER, A JOHNSON &JOHNSON IOL. NO INJURY OR ADDITIONAL INTERVENTION WAS REQUIRED. THE PATIENT HAS FULLY RECOVERED, AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 22649936 ↗
• MalfunctionJul 11, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON OBSERVED A TRIANGULAR GOUGE ON THE BACK OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) UPON IMPLANTATION. AS A RESULT, THE LENS WAS REMOVED AND REPLACED WITH THE SAME MODEL. THERE WAS NO REPORT OF ANY MEDICAL OR SURGICAL INTERVENTION NEEDED, AND THE PRODUCT IS BEING RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22486818 ↗
• InjuryMay 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO REFRACTIVE SURPRISE -1.75, PREVIOUS LASIK. IT WAS UNKNOWN IF UNPLANNED SUTURES WERE REQUIRED. ANOTHER JOHNSON & JOHNSON LENS, MODEL DIB00 18.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 21955922 ↗
• MalfunctionApr 17, 2025Break; Break

  THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) WAS REPORTED TO HAVE A HAPTIC MALFUNCTION, NO ADDITIONAL INFORMATION REGARDING THE TYPE OF HAPTIC MALFUNCTION IS AVAILABLE. THERE WAS NO PATIENT CONTACT WITH THE IOL AND NO PATIENT HARM. A BACK-UP LENS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860643 ↗
• MalfunctionApr 1, 2025Crack; Crack

  WHEN ADVANCING THE PRE-LOADED DIB00 MODEL INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE, WHEN IT WAS ABOUT 2MM FROM THE TIP, THE LENS/PLUNGER CAME OUT OF A CRACK IN THE SIDE OF THE CARTRIDGE, DAMAGING THE CARTRIDGE TIP. WHEN ASKED EXTENT OF PATIENT CONTACT, BOTH "CARTRIDGE TIP HAD PATIENT CONTACT" AND "LENS INSERTED AND REMOVED DURING SAME PROCEDURE" WERE GIVEN AS ANSWERS. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, NO VITRECTOMY, AND THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP LENS, DIB00 19.5 DIOPTER IOL - SN: (B)(6), THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THERE WAS AN APPROXIMATE TEN (10) MINUTE DELAY. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS GOOD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748962 ↗