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

Catalog Number	618.60
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Health Effect - Clinical Codes	Corneal Edema (1791); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
An investigator reported in a clinical study that while using a surgical macular lens during a vitreo retinal procedure a patient experienced with poor macular visualization and corneal edema due to previous phacoemulsification.
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).
Additional Manufacturer Narrative
Corrected information provided in section b.2, b.5, h.6 and h.10.The initial report was reported in error.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.No further reports will be reported under mfg report num.3003398873-2023-00063.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
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 deterioration the characteristics or performance in relation to the event.There is no indication of device failure as the device was used and performed as intended.

• 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: 17116111
• Report Number: 3003398873-2023-00063
• Device Sequence Number: 6820863
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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: 07/20/2023
• 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
• Patient Sex: Male