MAUDE Adverse Event Report: ALCON GRIESHABER AG CURVED MEMBRANE SCRAPER; SPATULA, OPHTHALMIC

Catalog Number	338.25P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No sample has been received by manufacturing for evaluation in regards to this literature report.The affected lot is number not known therefore, the device history record could not be reviewed.A 100% final inspection is performed for this product.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.No additional information is anticipated for this literature report.(b)(4) - [(b)(4)].
Event or Problem Description
A physician reported that a 25ga membrane scraper was used during a combination cataract and vitrectomy procedure.The patient presented postoperatively with retinal nerve fiber layer damage and paracentral scotoma that resolved at three months postop with bcva of 20/20.

• Brand Name: CURVED MEMBRANE SCRAPER
• Common Device Name: SPATULA, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• MDR Report Key: 8179139
• Report Number: 3003398873-2018-00041
• Device Sequence Number: 1792127
• Product Code: HND
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2018

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: 338.25P
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 25GA END GRASPING ILM FORCEPS; SULFUR HEXAFLUORIDE GAS, UNSPECIFIED AT 20
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR