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

Model Number 1MTEC30

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2017

Event Type  malfunction  

Manufacturer Narrative

Implant and explant dates: if implanted or explanted; give date: n/a (not applicable).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 intraocular lens (iol) was successfully implanted.When viscoelastic was being removed, a shard of plastic was noticed in the eye and removed by the surgeon.The cartridge was reported as defective.There was no incision enlargement and no patient injury.No additional information was provided to abbott medical optics.

Manufacturer Narrative

Device available for evaluation? yes, returned to manufacturer on 8/23/2017.Device returned to manufacturer? yes.Device evaluation: the cartridge was received in the original tray with tyvek lid.The particle of interest was received adhered to a covidian skin marker with tape.The piece of foreign material was submitted for analysis by fourier transform infrared (ftir).The ftir results indicate the transparent particle is consistent with a blend of a methacrylate and possibly a vinyl polymer similar to polyvinylpyrrolidone.An evaluation of the cartridge reveled lack of coating in the cartridge.The reported issue was verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.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 indication of a product quality deficiency.Additional investigation is being conducted and corrective actions will be implemented as required.All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

Additional information: fourier transform infrared spectroscopy (ftir) analysis indicates the returned shard plastic (transparent) particle is consistent with a blend of a methacrylate and possibly vinyl polymer similar to polyvinylpyrrolidone.Through the manufacturing process there are various controls in place for 1mtec30 cartridge products, where a visual inspection is performed at 10x magnification microscope inside a laminar flow hood for cosmetic defects including particles, fibers, and tip defect.Ionized air guns are used in the manufacturing areas to ensure removal of any look particles or material that could be introduced as part of the packaging process of the cartridges.Inspection of trays in the packaging process is also performed for debris.In addition, the manufacturing process is performed inside a regulated clean room class 7 manufacturing room that requires full gowning before entering the room.As the id laboratory results suggest that the transparent particle is consistent with a blend of a methacrylate and possibly vinyl polymer similar to polyvinylpyrrolidone, the transparent particle does not match any of the cartridge material found in the current coating process for 1mtec30 cartridge.On the other hand, the methacrylate is found in the soft acrylic iol process.The ethyl methacrylate (ema) is used in the formulation of material from which soft acrylic intraocular lenses are manufactured.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: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6822603
• MDR Text Key: 83744099
• Report Number: 2648035-2017-01552
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)180428(10)CC05272
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/28/2018
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CC05272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2017
• 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
• Patient Age: 76 YR