MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS SILVER; SURGICAL ADJUNCTS

Model Number SILVERT

Device Problem Device Handling Problem (3265)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Udi #:unknown since serial # is unknown, not provided.Age/date of birth: unknown, not provided.Sex/gender: unknown, not provided.Date of event: unknown, not provided.Serial # and expiration date: unknown, not provided.If implanted, give date: not applicable, not implanted.If explanted, give date: not applicable, not implanted, therefore not explanted.(b)(4).Device manufacture date: unknown since serial # is unknown, not provided.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported while using a sliver series injector to implant an intraocular lens from another manufacturer, the haptic bent during loading.The lens was inserted into the patient eye but had to be removed and replaced with another lens because of the damage haptic.The incision was required to be enlarged and sutures were used.Additionally, the surgery technician reported that it was handling/user error.No further information was provided.The lens implant manufacturer has filed an mdr and supplemental mdr for their reported lens.

• Brand Name: SILVER
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; 8600 evergreen blvd. n; minneapolis MN 55433 6036
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 5449234
• MDR Text Key: 38640895
• Report Number: 2183946-2016-00001
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: SILVERT
• Device Catalogue Number: SILVERT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention