iStent GTS100LRecalls & reported problems
Glaukos Corporation · Trabecular Micro-bypass stent system - Left · Class 3 · Implant
Quick summary
This Glaukos iStent GTS100L, an eye implant used to lower eye pressure in glaucoma surgery, has 107 reports, no deaths and 78 injuries. Some reports describe stents placed in the wrong position or blocked by iris tissue, and some describe eye pressure rising after surgery or bleeding inside the front of the eye. Other reports describe a small particle found on the stent. The latest report is dated August 2024. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 107
- Deaths reported
- 0
- Injuries reported
- 78
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 00853704002012), received between Aug 24, 2016 and Aug 29, 2024 — classified as 78 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (21 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem59
- Malposition of Device21
- Use of Device Problem17
- Obstruction of Flow8
- Contamination /Decontamination Problem2
- No Apparent Adverse Event2
- Break1
- Contamination1
Patient problems
- Eye Injury29
- Intraocular Pressure Increased28
- Hyphema19
- Foreign Body In Patient16
- Loss of Vision16
- No Consequences Or Impact To Patient10
- No Known Impact Or Consequence To Patient9
- Endophthalmitis5
Recent adverse event reports
The 25 most recent of 107 reports, in the reporter's own words as published by the FDA.
InjuryAug 29, 2024Obstruction of Flow; Obstruction of Flow
THE FOLLOWING WAS REPORTED THROUGH A REVIEW OF THE ARTICLE TITLED, "ONE-YEAR COMPARATIVE ANALYSIS BETWEEN STANDALONE ISTENT IMPLANTATION VERSUS COMBINED ISTENT IMPLANTATION WITH PHACOEMULSIFICATION." REPORTEDLY FOLLOWING TRABECULAR MICROBYPASS STENT PROCEDURES IN A TOTAL OF FORTY-EIGHT (48) EYES, TWO (2) OPERATIVE EYES PRESENTED DURING A POSTOPERATIVE EXAMINATION WITH STENT OCCLUSION WITH IRIS TISSUE. PER REPORT, NONE OF THE PATIENTS REQUIRED A SECONDARY GLAUCOMA PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. PLEASE SEE ATTACHED ARTICLE FOR FURTHER DETAILS. REFERENCE DOI:10.1177/11206721241273678.
Patient problems: No Clinical Signs, Symptoms or Conditions; Uveitis
MAUDE report 20100535 ↗MalfunctionMay 15, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT PRIOR TO A TRABECULAR MICRO BYPASS STENT PROCEDURE, A POTENTIAL FOREIGN PARTICULATE WAS OBSERVED IN THE STERILE WRAPPING OF AN UNOPENED DEVICE. THERE WAS NO PATIENT CONTACT OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11829954 ↗InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH A CLINICAL TRIAL THAT FOLLOWING LEFT EYE TRABECULAR MICRO BYPASS STENT PROCEDURE, A SUBJECT PRESENTED WITH MODERATE IOP INCREASE THIRTY-TWO (32) MONTHS POSTOPERATIVELY. A SELECTIVE LASER TRABECULOPLASTY (SLT) WAS PERFORMED AND THE PATIENT WAS REPORTED ON ONE (1) GLAUCOMA MEDICATION (LATANOPROST) AND WAS BEING MONITORED. THROUGH FOLLOW-UP, IT WAS REPORTED THAT DURING THE MOST RECENT FOLLOW-UP VISIT THE SURGEON WAS COMFORTABLE WITH THE PATIENT IOP VALUE, AND THERE WAS NO CHANGE IN MEDICATION WITH NO NEW ADVERSE EVENT.
Patient problems: Intraocular Pressure Increased
MAUDE report 11008601 ↗InjuryJun 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CLINICAL FOLLOW-UP WAS RECEIVED WITH THE FOLLOWING ADDITIONAL INFORMATION. REPORTEDLY, THE PATIENT PRESENTED APPROXIMATELY TWO (2) YEARS AND FOUR (4) MONTHS POST-OP WITH INTRAOCULAR INFLAMMATION (IRITIS) REMAINING OR ARISING AFTER COMPLETION OF THE PROTOCOL¿S SPECIFIED MEDICATION REGIMEN. THE INFLAMMATION WAS CHARACTERIZED AS MODERATE (POSSIBLY RELATED TO THE STUDY TREATMENT) AND WAS TREATED WITH MEDICATION. THE PATIENT¿S MOST RECENT PROGNOSIS WAS REPORTED AS ¿RECOVERED¿. THE SURGEON DOUBTS THE IRITIS WAS CAUSED BY THE STENT, BUT COULD NOT BE COMPLETELY RULE IT OUT. THIS REPORT REFERENCE MFR# REFERENCE: (B)(4). PLEASE REFERENCE MFR# REFERENCE (B)(4) THE INITIAL REPORTED OCCURENCE.
Patient problems: Iritis
MAUDE report 10115257 ↗MalfunctionJan 6, 2020No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED DURING A LEFT EYE CATARACT PLUS TRABECULAR MICRO BYPASS STENT PROCEDURE, THE SURGEON OBSERVED A PARTICULATE DESCRIBED AS A ¿SMALL WHITE FRAGMENT¿. PER REPORT, THE PARTICULATE APPEARED TO COME FROM THE LUMEN OF THE STENT, OBSERVED AFTER IMPLANTATION. THE SURGEON MANAGED TO REMOVE PART OF THE PARTICULATE, BUT SOME PARTICULATE REMAINED ON THE STENT. SUBSEQUENTLY, THE SURGEON REMOVED THE STENT FROM THE PATIENT¿S EYE INTRAOPERATIVELY. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9555146 ↗MalfunctionDec 19, 2019Malposition of Device; Malposition of Device
IT WAS INITIALLY REPORTED THAT DURING A LEFT EYE CATARACT PLUS TRABECULAR MICRO BYPASS STENT PROCEDURE, THE SURGEON WAS UNABLE TO PROPERLY IMPLANT THE STENT IN THE RIGHT POSITION (IN THE TRABECULAR MESHWORK). PER REPORT, SURGICAL TECHNIQUE AND EXPERIENCE WITH DEVICE CONTRIBUTED TO THE REPORTED EVENT. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY AND THERE WAS NO SURGICAL OR MEDICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED AND THE SURGEON REPORTED THAT AFTER IMPLANTATION ATTEMPT, THE STENT COULD NOT BE LOCATED. IT IS UNKNOWN IF THE DEVICE REMAINS IN THE PATIENT'S EYE AS THE SURGEON COULD NOT LOCATE IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 9497111 ↗InjuryNov 7, 2019Malposition of Device; Malposition of Device
INITIALLY, A TRABECULAR MICRO BYPASS STENT PATIENT REPORTED THE FOLLOWING EVENT. FOLLOWING AN UNEVENTFUL LEFT EYE CATARACT PLUS STENT PROCEDURE, THE PATIENT PRESENTED ON POST-OP DAY ONE (1) WITH ELEVATED IOP AND THE SURGEON WAS UNABLE TO VISUALIZE THE STENT. ADDITIONAL GLAUCOMA MEDICATIONS WERE PRESCRIBED AND THE IOP IMPROVED. REPORTEDLY, THE PATIENT WAS INFORMED THAT THE STENT WAS "LOST", AND A STENT WAS SUBSEQUENTLY IMPLANTED IN THE LEFT EYE APPROXIMATELY TWO (2) WEEKS FOLLOWING THE INITIAL IMPLANT. THE PATIENT ALSO REPORTED BLURRY VISION AND "ABNORMAL MACULA" FOLLOWING THE INITIAL OPERATION. PER PATIENT, THE MACULA HAS AN "ABNORMAL CURVE". THROUGH FOLLOW-UP, THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. THE PROCEDURE WAS UNEVENTFUL AND THE SURGEON WAS UNCERTAIN ABOUT WHAT CONTRIBUTED TO STENT MALPOSITIONING. POSTOPERATIVELY, THE STENT WAS VISUALIZED IN ANGLE, BUT NOT IN THE TRABECULAR MESHWORK (TM). THE STENT POSITIONING DID NOT RESULT IN ANY ADVERSE IMPACT. PER REPORT, THE STENT WAS REPOSITIONED AT PATIENT REQUEST. THE SURGEON NOTED THAT THE IOP DID NOT REQUIRE INTERVENTION BEYOND STANDARD POSTOP REGIMEN AS IT IS EXPECTED TO RISE AT DAY ONE (1) POSTOP FOR GLAUCOMA
Patient problems: Intraocular Pressure Increased
MAUDE report 9291770 ↗MalfunctionAug 7, 2019Obstruction of Flow; Obstruction of Flow
THE FOLLOWING WAS REPORTED THROUGH A REVIEW OF AN ARTICLE TITLED "CASE SERIES OF COMBINED ISTENT IMPLANTATION AND PHACOEMULSIFICATION IN EYES WITH PRIMARY ANGLE CLOSURE DISEASE: ONE-YEAR OUTCOMES". FOLLOWING CATARACT PLUS TRABECULAR MICRO BYPASS STENT PROCEDURES, THERE WERE OCCLUSION OF STENTS WITH IRIS IN TEN (10 ) EYES, HYPHEMA (7), IRIS ATROPHY (2), ELEVATED IOP (1), IRIDODIALYSIS (1), CORNEAL EDEMA (1). THE REPORT INDICATES THAT ALL COMPLICATIONS WERE MANAGED CONSERVATIVELY WITHOUT REQUIRING A SECOND SURGERY AND THERE WAS NO OCCURRENCE OF SIGHT-THREATENING COMPLICATIONS. REPORTEDLY, AMONG THE TEN (10) EYES WITH REPORTED STENT OCCLUSION, EIGHT (8) EYES HAD A SINGLE STENT IMPLANTED, AND TWO (2) EYES HAD TWO (2) STENTS IMPLANTED. THE REPORT NOTES THAT THE OCCLUSION OCCURRED IN SEVEN (7) EYES WITHIN THE FIRST 2 MONTHS AFTER THE SURGERY AND GLAUCOMA MEDICATIONS WERE SUBSEQUENTLY REQUIRED IN THREE (3) OF THE TEN (10) EYES. IN ADDITION, FIVE (5) OF THE EIGHT (8) EYES WITH A SINGLE STENT IN SITU WAS FULLY OCCLUDED WITH IRIS AND THE REMAINING FIVE (5) EYES PRESENTED WITH PARTIALLY OCCLUDED STENTS. THROUGH FOLLOW UP DEVICE IDENTIFIERS WERE PROVIDED FOR 2 OF THE REPORTED STENT OCCLUSION E
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8870403 ↗InjuryJul 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOLLOWING A RIGHT EYE CATARACT PLUS TRABECULAR MICRO BYPASS STENT PROCEDURE, THE SURGEON EXPLANTED THE STENT APPROXIMATELY 2+ YEARS POSTOPERATIVELY DUE TO LACK OF DESIRED IOP REDUCTION. SUBSEQUENTLY, THE SURGEON PERFORMED AN AB INTERNO TRABECULECTOMY (KAHOOK DUAL BLADE). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Therapeutic Response, Decreased
MAUDE report 8778848 ↗MalfunctionJun 26, 2019Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THROUGH A CLINICAL TRIAL THAT A SUBJECT PRESENTED WITH STENT OBSTRUCTION IN THE LEFT EYE; APPROXIMATELY, ONE (1) YEAR POSTOPERATIVELY. THE OSTIUM OF STENT WAS OBSERVED COVERED WITH THE TRABECULAR MESHWORK (TM) TISSUE. THERE WAS NO REPORT OF SURGICAL/MEDICAL INTERVENTION PERFORMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8737461 ↗InjuryMay 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED FOLLOWING CATARACT PROCEDURE, THE PATIENT MOVED DURING IMPLANTATION ATTEMPT OF A TRABECULAR MICRO BYPASS STENT. DUE TO PATIENT MOVEMENT, AN INTRAOPERATIVE IRIS TEAR OCCURRED. THE STENT PROCEDURE WAS ABORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Eye Injury
MAUDE report 8647451 ↗InjuryMar 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A LEFT EYE OMNI PROCEDURE, A TRABECULAR MICRO BYPASS STENT DISLODGED FROM THE TRABECULAR MESHWORK (TM) AFTER THE GONIO EXAMINATION. INITIALLY, THE PATIENT UNDERWENT THE LEFT EYE CATARACT PLUS TRABECULAR MICRO BYPASS STENT PROCEDURE APPROXIMATELY TWENTY (20) MONTHS PRIOR TO OMNI PROCEDURE. THE STENT WAS REMOVED FROM THE PATIENT¿S EYE SUCCESSFULLY. ADDITIONAL INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8438432 ↗MalfunctionMar 18, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THAT FOLLOWING A RIGHT EYE CATARACT PROCEDURE, A TRABECULAR MICRO BYPASS STENT WAS ¿LOST¿ DURING IMPLANTATION ATTEMPT. THERE WAS NO REPORT OF PATIENT¿S INJURY. ADDITIONAL INFORMATION (CLARIFICATION) WAS REQUESTED, BUT FURTHER DETAILS WERE NOT AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 8428945 ↗InjuryJan 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOLLOWING CATARACT SURGERY, DURING ATTEMPT TO IMPLANT A STENT FROM A TRABECULAR MICRO-BYPASS STENT, THE PATIENT MOVED RESULTING IN AN IRIDODIALYSIS. THE PROCEDURE WAS ABORTED. ADDITIONAL INFORMATION IS BEING REQUESTED.
Patient problems: Eye Injury
MAUDE report 8224671 ↗MalfunctionNov 2, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THROUGH FOLLOW-UP, THE SURGEON PROVIDED THE FOLLOWING UPDATE. REPORTEDLY, THE STENT APPEARED WELL POSITIONED POSTOPERATIVELY. PER THE SURGEON, IT IS UNCLEAR IF THE FOREIGN BODY (FB) OBSERVED WAS A METALLIC FB ON THE IRIS AS IT WAS "HARDLY" VISIBLE. THE PROGNOSIS WAS REPORTED AS ¿GOOD¿ WITHOUT ADVERSE EVENT.
Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient
MAUDE report 8034370 ↗MalfunctionOct 16, 2018No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT FOLLOWING A RIGHT EYE CATARACT PROCEDURE, THE SURGEON WAS UNABLE TO IMPLANT A TRABECULAR MICRO BYPASS STENT IN THE OPERATIVE EYE (OD). THE SURGEON SUBSEQUENTLY PERFORMED GONIOTOMY AND THERE WAS NO PATIENT INJURY. PER REPORT, THE LOCATION OF THE STENT COULD NOT BE CONFIRMED (UNKNOWN) AFTER UNSUCCESSFUL IMPLANTATION ATTEMPT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7970075 ↗InjuryOct 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOLLOWING A LEFT EYE CATARACT SURGERY, THE PATIENT CONTINUOUS ¿ABRUPT¿ HEAD MOVEMENT DURING ATTEMPTED IMPLANTATION OF A TRABECULAR MICRO-BYPASS STENT CAUSED THE SURGEON TO INADVERTENTLY CREATE AN IRIDOTOMY WITH THE STENT. THE STENT WAS REMOVED FROM THE PATIENT¿S EYE AND THE PROCEDURE WAS ABORTED. ADDITIONAL INFORMATION IS BEING REQUESTED.
Patient problems: Eye Injury
MAUDE report 7957119 ↗InjurySep 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOLLOWING A RIGHT EYE CATARACT PROCEDURE, THE PATIENT MOVED HIS HEAD DURING A TRABECULAR MICRO-BYPASS STENT PROCEDURE WHICH RESULTED IN APPROXIMATELY 3 CLOCK HOURS OF IRIDODIALYSIS SUPERONASALLY. THE STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT¿S EYE, AND THE PROCEDURE WAS ABORTED. REPORTEDLY, THE PATIENT MAY NEED IRIDOPLASTY IN THE FUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Eye Injury
MAUDE report 7914763 ↗InjurySep 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOLLOWING CATARACT PLUS TRABECULAR MICRO-BYPASS STENT SURGERY, THE PATIENT PRESENTED WITH ENDOPHTHALMITIS IN THE OPERATIVE EYE (OD) FIVE (5) DAYS POST-OP. VITRECTOMY WAS SUBSEQUENTLY PERFORMED ON (B)(6) 2018. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Endophthalmitis; Hypopyon; Iritis; Uveitis; Vitrectomy
MAUDE report 7891857 ↗MalfunctionSep 19, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT PRIOR TO PATIENT CONTACT, A FOREIGN MATERIAL WAS OBSERVED IN THE PACKAGING OF AN UNOPENED TRABECULAR MICRO-BYPASS STENT. THERE WAS NO PATIENT CONTACT AS THE PRODUCT WAS NOT USED. A BACK-UP STENT WAS IMPLANTED SUCCESSFULLY.
Patient problems: No Patient Involvement
MAUDE report 7891590 ↗InjuryMay 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION TO GLAUKOS ON 07/02/2018. THE ISTENT PROCEDURE WAS ABORTED DUE A GRADE I HYPHEMA (LESS THAN OR EQUAL TO 1/3 ANTERIOR CHAMBER VOL.) WHICH RESULTED IN IOP ELEVATION AND "TEMPORARY BCVA LOSS. THE HYPHEMA WAS TREATED BY INCREASING STEROIDS AND DILATATION DROPS. PARS PLANA VITRECTOMY (PPV) AND ANTERIOR CHAMBER WASHOUT WERE PERFORMED ONE MONTH POST-OP. THE PATIENT WAS PRESCRIBED COMBIGAN AND LUMIGAN AND WILL CONTINUE TO BE MONITORED. ACCORDING TO THE SURGEON, THE ADVERSE EVENT RESOLVED, AND HYPHEMA LIKELY CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT CURRENT STATUS WAS REPORTED AS "IMPROVED, VISION BACK TO BASELINE".
Patient problems: Eye Injury; Hyphema; Intraocular Pressure Increased; Loss of Vision
MAUDE report 7520753 ↗MalfunctionApr 30, 2018Malposition of Device; Malposition of Device
AS REPORTED DURING A TRABECULAR MICRO-BYPASS STENT SURGICAL PROCEDURE OF THE LEFT EYE, ¿THERE WAS TOO MUCH BLOOD¿ AND THE STENT WAS LOST EITHER INSIDE OR OUTSIDE OF THE PATIENT¿S EYE. THE SURGEON ATTEMPTED TO VISUALIZE THE STENT USING AN ENDOSCOPIC CAMERA, BUT WAS UNABLE TO LOCATE THE STENT. THE TRABECULAR MICRO-BYPASS STENT SURGERY WAS ABORTED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WILL BE REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 7474797 ↗InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN ISTENT PATIENT PRESENTED APPROXIMATELY ONE MONTH POST-OP WITH POTENTIAL IRIS/SNORKEL TOUCH. SOME CELLS WERE OBSERVED IN THE ANTERIOR CHAMBER REQUIRING TREATMENT WITH DUREZOL DROPS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Inflammation
MAUDE report 7463392 ↗MalfunctionApr 25, 2018Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device
IT WAS REPORTED THAT THE SURGEON INADVERTENTLY PLACED THE STENT IN THE CILIARY BODY BAND. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE STENT BUT EVENTUALLY THE SURGEON DECIDED TO LEAVE IT WHERE IT WAS TO PREVENT POSSIBLE DAMAGE IN ATTEMPTS AT RETRIEVING IT. THE STENT WAS VISIBLE AT THE END OF THE CASE. A BACKUP STENT WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 7463381 ↗MalfunctionApr 18, 2018Malposition of Device; Malposition of Device
THE SURGEON REPORTED THAT A TRABECULAR MICRO BYPASS STENT WAS UNABLE TO BE IMPLANTED DUE TO COMPROMISED VISUALIZATION DURING THE SURGICAL PROCEDURE. A SECOND TRABECULAR MICRO BYPASS STENT WAS USED. THE PATIENT MOVED DURING IMPLANTATION ATTEMPT AND THE SURGEON INADVERTENTLY RELEASED THE STENT POSTERIOR TO THE IMPLANTATION SITE. AN ATTEMPT TO RETRIEVE THE STENT WAS MADE BUT IT BECAME EMBEDDED IN IRIS TISSUE. THE SURGEON MADE THE DECISION TO LEAVE THE STENT AND THE PROCEDURE WAS ABORTED. CLINICAL FOLLOW-UP WAS REQUESTED AND ON 04/16/2018 THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL DETAILS: THE STENT'S POSITIONING DID NOT RESULT IN ANY ADVERSE IMPACT TO THE PATIENT AND IS BEING MANAGED BY MONITORING THE PATIENT. THE PATIENT'S CURRENT STATUS AND PROGNOSIS WAS DESCRIBED AS "PROGRESSING WELL FROM CATARACT SURGERY. WILL STILL NEED GLAUCOMA MEDICATIONS WHEN RECOVERED FROM SURGERY." THE ISTENT IS IN A STABLE POSITION.
Patient problems: Foreign Body In Patient
MAUDE report 7441151 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.