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

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

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

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Brand name: unknown as a model was not provided.Model number: unknown, was not provided.Expiration date: unknown, as the lot number was not provided.Lot number: unknown, information not provided.Udi number: unknown, as the lot number was not provided.Catalog number: unknown, as model was not provided.If implanted, give date: not applicable, as the device is not implantable.If explanted, give date: not applicable, as the device is not implantable.Pma/510(k): unknown, as a model was not provided.Device manufacture date: unknown as product lot number was not provided.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that the doctor noticed a film in the capsular bag after implanting a zcb00 intraocular lens (iol) on (b)(6) 2017 and couldn''t tell if it was from the cartridge or healon ophthalmic viscosurgical device (ovd).Reportedly, it was able to be removed without incident.No additional information was provided.This report represents the cartridge, a second report will be provided for the healon.

Manufacturer Narrative

Additional information: it was reported during follow up that there are multiple cases however, an exact number of cases is unknown.All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

Device evaluation: the product was not returned.However, a photo was provided by the customer.There is some color discontinuity shown in the photo that suggests the possibility of foreign material in the eye (capsule).We are unable to discern what that color discontinuity observed in the photo is or if is related to the lens or is part of the patient eye/anatomy.Since the reported issue is that there is something noticed in the eye, it is verified although we cannot determine if it is related to manufacturing process.Manufacturing records review: the manufacturing record cannot be reviewed since the product identity is unknown.Product identifiers are not available therefore a complaint history could not be performed.Labeling review: product identity is unknown.Therefore, a labeling review could not be performed.Conclusion: since product identifiers were not provided and based on the photo provided we are unable to determine if there was a product malfunction or product quality deficiency.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: UNKNOWN
• 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: 6939177
• MDR Text Key: 90065858
• Report Number: 2648035-2017-01850
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2017
• 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