Alcon Grieshaber 618.60Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07612717071285), received between Jun 12, 2023 and Jun 29, 2023 — classified as 11 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORTED RECEIVED VIA CLINICAL STUDY THAT OPHTHALMIC SURGICAL CONTACT LENS USED FOR THE VITREORETINAL SURGERY AFTER THE SURGERY PATIENT EXPERIENCED INFLAMMATION, IRRITATION FOR WHICH THE EVENT REQUIRED INTERVENTION (UNKNOWN IF SURGICAL OR MEDICAL). THE SYMPTOMS ARE IMPROVING. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Irritability

  MAUDE report 17223399 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED VIA A CLINICAL STUDY THAT AFTER A VITRECTOMY SURGERY WITH THE USE OF AN OPHTHALMIC DISPOSABLE PRODUCT A PATIENT EXPERIENCED IRRITATION AND RETINAL INFLAMMATION. THE PATIENT REQUIRED INTERVENTION (UNKNOWN IF SURGICAL OR MEDICAL) AND THE EVENT IS RESOLVED. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Irritability

  MAUDE report 17207666 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL STUDY REVEALED THAT DURING THE MEMBRANE PEELING SURGERY WHILE USING DISPOSABLE LENS A MALE PATIENT EXPERIENCED OCULAR TOXICITY (MACULAR) RESPONSE. PATIENT SYMPTOM'S WAS RESOLVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17198722 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL SURVEY REVEALED THAT AFTER VITRECTOMY SURGERY A FEMALE PATIENT EXPERIENCED WITH MILD HYPEREMIA. UNKNOWN INTERVENTION WAS PERFORMED TO TREAT THE PATIENT. CURRENT PATIENT SYMPTOMS WERE RESOLVED.

  Patient problems: Hyperemia

  MAUDE report 17190309 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA CLINICAL STUDY THAT DURING A VITRECTOMY SURGERY WHILE USING AN OPHTHALMIC DISPOSABLE PRODUCT THE PATIENT EXPERIENCED CORNEAL ABRASION AND PATIENT REQUIRED INTERVENTION (UNKNOWN IF SURGICAL OR MEDICAL) . PATIENT'S CONDITION IS RESOLVED. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY.

  Patient problems: Corneal Abrasion

  MAUDE report 17117702 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA CLINICAL STUDY THAT DURING A VITRECTOMY SURGERY WHILE USING AN OPHTHALMIC DISPOSABLE PRODUCT THE PATIENT EXPERIENCED RETINAL DETACHMENT. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY.

  Patient problems: Retinal Detachment

  MAUDE report 17117286 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA A CLINICAL STUDY THAT DURING A VITRECTOMY SURGERY WHILE USING AN OPHTHALMIC DISPOSABLE PRODUCT A PATIENT EXPERIENCED RETINAL DETACHMENT AND RECURRENT BLEEDING. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Retinal Detachment

  MAUDE report 17116308 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  THE INITIAL REPORT WAS REPORTED IN ERROR. THE CORRECT REPORTED EVENT REPORTED VIA CLINICAL STUDY IS FOR ¿POOR MACULAR VISUALIZATION¿ DUE TO BEING A COMBINED SURGERY. ALSO, IT WAS INDICATED A HISTORY OF CORNEAL EDEMA WAS DUE TO PREVIOUS PHACOEMULSIFICATION (PHACO) SURGERY AND POOR PATIENT COLLABORATION. THIS EVENT OF POOR MACULAR VISUALIZATION DURING SURGERY WHILE USING A MACULAR LENS DOES NOT MEET REPORTING CRITERIA BECAUSE THE PRODUCT ¿DID NOT DIRECTLY OR INDIRECTLY LED, MIGHT HAVE LED, OR MIGHT LEAD TO ANY OF THE FOLLOWING: (A) THE DEATH OF A PATIENT, USER OR OTHER PERSON, (B) THE TEMPORARY OR PERMANENT SERIOUS DETERIORATION OF A PATIENT'S, USER'S OR OTHER PERSON'S STATE OF HEALTH. THERE IS NO INDICATION THAT REASONABLY SUGGESTS THE DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY ON RE OCCURRENCE. THE REPORTED DEVICE USED DURING THE PROCEDURE IS USED ON THE ANTERIOR SURFACE OF THE EYE TO VISUALIZE FUNDUS AND RETINAL STRUCTURES DURING VITREORETINAL SURGERIES AND IS NOT USED IN THE INTERIOR OF THE EYE TO EXECUTE AND OR PERFORM A SURGICAL ACTION. THERE IS NO INDICATION THAT THE DEVICE CONTRIBUTED TO THE EVENT OR ANY ALLEGATION THAT OF A DEVICE MALFUNCTION OR DETERI

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Edema; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17116111 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INITIAL REPORT WAS REPORTED IN ERROR. AN INVESTIGATOR REPORTED IN A CLINICAL STUDY THAT WHILE USING A SURGICAL MACULAR LENS A PATIENT EXPERIENCED ¿SUBCONJUNCTIVAL BLEEDING AS LENS WAS RUBBING ON THE LIMBUS ¿ DURING A VITREORETINAL SURGERY. THE SYMPTOMS WERE RESOLVED. FOR THIS EVENT; THIS REPORT OF ¿SUBCONJUNCTIVAL BLEEDING¿ DOES NOT MEET REPORTING CRITERIA AS PER APPLICABLE REGULATIONS BECAUSE THE INCIDENT DID NOT DIRECTLY OR INDIRECTLY LED TO A ¿TEMPORARY OR PERMANENT SERIOUS DETERIORATION OF A PATIENT'S, USER'S OR OTHER PERSON'S STATE OF HEALTH¿, AND ¿DID NOT RESULTED IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR NECESSITATED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE.¿

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17116009 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INITIAL REPORT WAS REPORTED IN ERROR. AN INVESTIGATOR REPORTED IN A CLINICAL STUDY THAT WHILE USING A SURGICAL MACULAR LENS A PATIENT EXPERIENCED ¿CORNEAL ABRASION WITH LUBRICANTS ADMINISTERED¿ DURING A VITREORETINAL SURGERY. THE SYMPTOMS WERE RESOLVED. FOR THIS EVENT; THIS REPORT OF ¿CORNEAL ABRASION¿ DOES NOT MEET REPORTING CRITERIA AS PER APPLICABLE REGULATIONS BECAUSE THE INCIDENT DID NOT DIRECTLY OR INDIRECTLY LED TO A ¿TEMPORARY OR PERMANENT SERIOUS DETERIORATION OF A PATIENT'S, USER'S OR OTHER PERSON'S STATE OF HEALTH¿, AND ¿DID NOT RESULTED IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR NECESSITATED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE.¿

  Patient problems: Corneal Abrasion

  MAUDE report 17115827 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INITIAL REPORT WAS REPORTED IN ERROR. AN INVESTIGATOR REPORTED IN A CLINICAL STUDY THAT WHILE USING A SURGICAL MACULAR LENS A PATIENT EXPERIENCED ¿INFLAMMATION¿ DURING A VITREORETINAL SURGERY. THE SYMPTOMS WERE RESOLVED. FOR THIS EVENT; THIS REPORT OF ¿INFLAMMATION¿ DOES NOT MEET REPORTING CRITERIA AS PER APPLICABLE REGULATIONS BECAUSE THE INCIDENT DID NOT DIRECTLY OR INDIRECTLY LED TO A ¿TEMPORARY OR PERMANENT SERIOUS DETERIORATION OF A PATIENT'S, USER'S OR OTHER PERSON'S STATE OF HEALTH¿, AND ¿DID NOT RESULTED IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR NECESSITATED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE.¿

  Patient problems: Macular Edema; Swelling/ Edema

  MAUDE report 17106013 ↗