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

Model Number PSCST30

Device Problems Bent (1059); Sticking (1597); Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that a doctor noticed that the tip of a pscst30 cartridge, lot# unknown, was deformed prior to surgery, however, he used it.It was stated that as a result, cornea had load during implanting of the intraocular lens (iol) in the left eye.First haptic was stuck to the part of deformed tip.It was further stated that the haptic bent and slightly stood in the patient's eye.In addition, it was stated that there was a negative consequence for cornea endothelium.The day after surgery, the cornea had opacity.At that time, eyesight was 0.01.As of (b)(6) 2014, the eyesight had recovered to 0.8 and the quantity of corneal endothelial cells was unknown.Patient outcome was uncorrected visual acuity (ucva) 20/25, and a best corrected visual acuity (bcva) 20/16, and -5d (diopter) astigmatism.The number of corneal endothelial cells pre-operatively was 2600 and 1200 post operatively.No further information was provided.

Manufacturer Narrative

Date of event: unknown.Expiration date: unknown; if implanted, give date: not known/applicable; if explanted, give date: not known/applicable.(b)(4).Device manufacture date: unknown.All pertinent information available to abbott medical optics has been submitted.Placeholder.

Manufacturer Narrative

An emdr will be filed for the amo intraocular lens.Lot #: cm02156.Expiration date: 11/21/2014.Concomitant product: amo intraocular lens, model z9002.Device manufacture date: 11/21/2013.(b)(4).All pertinent information available to abbott medical optics has been submitted.Placeholder.

• Brand Name: SILVER
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): .; amo, puerto rico, inc.; road 402 north, km 4.2; anasco PR 00610
• Manufacturer Contact: stephanie solomon ; abbott medical optics inc.; 1700 east st. andrew place; santa ana, CA 92705 ; 7145663731
• MDR Report Key: 3819369
• MDR Text Key: 4405339
• Report Number: 2648035-2014-00257
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2014

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
• Device Operator: Physician
• Device Expiration Date: 11/21/2014
• Device Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Device Lot Number: CM02156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 05/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INTRAOCULAR LENS, BRAND/TYPE UNKNOWN
• Patient Outcome(s): Other
• Patient Age: 75 YR