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

Model Number 1MTEC30

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

Lot#: unknown/not provided.Catalog#: a complete catalog # is unknown, as product lot number was not provided.Expiration date: unknown as product lot number was not provided.Udi #: a complete udi # is unknown as product lot number was not provided.If implanted; give date: n/a (not applicable).The cartridge is not an implantable device.If explanted; give date: n/a (not applicable).The cartridge is not an implantable device; therefore, not explanted.(b)(6).Device manufacture date: unknown as product lot number was not provided.Device evaluation: the complaint cartridge was received in a plastic bag.A dent on the tip of the cartridge was observed.The reported issue was verified.Manufacturing records review: a manufacturing record review and complaint history review could not be performed since the lot number is unknown.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 abbott medical optics has been submitted.

Event Description

It was reported that during the implantation of the intraocular lens (iol) using the 1mtec30 cartridge, it was difficult to insert the tip part of this cartridge into the incision due to the tip being deformed.However, the doctor implanted the iol safely.There was no patient injury.No additional information was provided to abbott medical optics.

• 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: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6863564
• MDR Text Key: 86093257
• Report Number: 2648035-2017-01649
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(10)UNKNOWN
• 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
• Report Date: 09/13/2017

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: 08/31/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 09/13/2017
• 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