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

Model Number 1MTEC30

Device Problems Crack (1135); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that during an implantation of an intraocular lens using a cartridge, model 1mtec30, the physician noticed that the tip of the cartridge was chipped and a debris went into the patient's eye.The debris was removed and the lens was implanted safely.No patient injury was reported.No further information was provided.

Manufacturer Narrative

Device available for evaluation - yes, device returned on the 01/26/2016.The cartridge was returned to the manufacturing site for inspection.Evidence of viscoelastic ovd (ophthalmic viscosurgical device) residue was detected inside the cartridge.A hole was observed at the bottom of the cartridge tube and the tip was noticed deformed.The customer's reported complaint was verified.Manufacturing records reviews: since the serial number is unknown the manufacturing record evaluation cannot be performed.Labeling review: the directions for use, (dfu) instructions were reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the cartridges and intraocular lenses.Correction: in the initial mdr, serial number unknown was entered.The cartridge is actually identified by a lot number and therefore, has been corrected to lot #: unknown.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: PLATINUM 1 SERIES
• 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: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 5383013
• MDR Text Key: 36511303
• Report Number: 2648035-2016-00099
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2015
• Initial Date FDA Received: 01/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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