MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS 1 SERIES ULTRA CARTRIDGE; SURGICAL ADJUNCTS

Model Number	1VIPR30
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	08/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, cartridge is not an implanted device.If explanted, give date: not applicable, cartridge is not an implanted device.Concomitant products: intraocular lens.Concomitant products: d and k inserter, model dk7791.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the doctor saw two small spots of cartridge lubricant on an intraocular lens (iol) after the lens was implanted.The lens was implanted in the left eye with use of a model 1vipr30 cartridge with a dk7791 twist inserter.Reportedly, there was no patient complication or injury and this was not interfering with activities of daily life.The intraocular lens remains implanted.The patient visited the doctor 1 day after surgery and is normal with an uncorrected distance visual acuity of 20/30 -2 on the snellen chart.Also, the patient had no ocular symptom complaints.Medical findings of +1 cells and a small cortical remnant was noted out of the visual field.No additional information was provided.
Additional Manufacturer Narrative
Additional information received reported the doctor observed typical debris on the lens surface from excess lubricant.No additional information was provided.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation, there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: 1 SERIES ULTRA CARTRIDGE
• Common Device Name: SURGICAL ADJUNCTS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 6860659
• Report Number: 2648035-2017-01638
• Device Sequence Number: 10952836
• Product Code: KYB
• UDI-Device Identifier: 05050474534605
• UDI-Public: (01)05050474534605(17)180217(10)CC02139
• Combination Product (Y/N): N
• Initial Reporter Country: SV
• PMA/510(K) Number: K081545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/17/2018
• Device Model Number: 1VIPR30
• Device Catalogue Number: 1VIPR30
• Device Lot Number: CC02139
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2017
• Supplement Date Received by Manufacturer: 01/02/2018; 01/26/2018
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 01/25/2018; 02/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR