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

Model Number PSCST30

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

The cartridge is not an implantable device; therefore, not explanted.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that the haptic got caught in the inserter during insertion of the intraocular lens (iol) into the eye.The iol was partially inserted into the eye.There was no vitrectomy, no incision enlargement, no patient injury and no sutures required.The procedure was completed using a backup iol of the same model and power.No additional information was provided to abbott medical optics.

Manufacturer Narrative

Device evaluation: the cartridge was not received for investigation.The reported issue could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: SILVER
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7262692
• MDR Text Key: 99996623
• Report Number: 2648035-2018-00230
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(17)180327(10)CC03788
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/27/2018
• Device Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Device Lot Number: CC03788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2017
• 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