MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS; MONOFOCAL IOLS

Model Number	ZA9003
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	07/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, not provided.Gender/sex: unknown/not provided.If implanted, give date: not applicable, lens was not implanted.If explanted, give date: not applicable, lens was not implanted, therefore not explanted.(b)(4).Device evaluation: the intraocular lens was returned to the manufacturing site for investigation.The lens was evaluated and no damage was observed.The haptics were observed to be correct and the lens was folded as required.The customer's reported event could not be confirmed.Manufacturing record review: a review of the manufacturing records was performed.The manufacturing process record was evaluated and the lenses were manufactured within specifications.The units were released according to specification.A search on complaints was performed and no other complaints were identified in this production order.Labeling evaluation: the directions for use (dfu) was reviewed.The dfu adequately provides instructions, precautions, along with warnings for the proper use and handling of the product.Based on the results of the investigation, no product deficiency was identified.All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that during implantation of a za9003 16.5 diopter intraocular lens (iol) the physician experienced loading issues.The physician was unable to load the iol on deployment.Incision enlargement and vitrectomy were required.There was no patient injury reported.No further information was provided.
Additional Manufacturer Narrative
Additional info: additional information was received and it was learnt that the patient was a (b)(6) female.Reportedly, there was no patient anatomy issue and another lens, same model and diopter, was successfully implanted.Updated age/date of birth: (b)(6).Gender/sex: female.Concomitant medical products: emeraldc30 cartridge, lot cb39339.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6758359
• Report Number: 2648035-2017-01411
• Device Sequence Number: 877704
• Product Code: HQL
• UDI-Device Identifier: 05050474528949
• UDI-Public: (01)05050474528949(17)211123
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/23/2021
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Initial Date Received by Manufacturer: 07/06/2017
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR