MAUDE Adverse Event Report: ALCON GRIESHABER AG GRIESHABER DSP SURGICAL CONTACT LENS; LENS, FUNDUS, HRUBY, DIAGNOSTIC

Catalog Number	618.60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Corneal Abrasion (1789)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported via clinical study that during a vitrectomy surgery while using an ophthalmic disposable product the patient experienced corneal abrasion.Perioperative corneal erosion successfully treated with lubricants and the event was resolved.
Event or Problem Description
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.¿.
Additional Manufacturer Narrative
The reported event was reported in error.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.The event corneal abrasion with lubricants administered 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.¿.No further reports will be reported under mfg report num.3003398873-2023-00061.The manufacturer internal reference number is: (b)(4).

• Brand Name: GRIESHABER DSP SURGICAL CONTACT LENS
• Common Device Name: LENS, FUNDUS, HRUBY, DIAGNOSTIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer (Section G): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17115827
• Report Number: 3003398873-2023-00061
• Device Sequence Number: 6612440
• Product Code: HJI
• UDI-Device Identifier: 07612717071285
• UDI-Public: 07612717071285
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 618.60
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male