MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: the lens was not returned to the manufacturer for evaluation.Visual inspection could not be performed, therefore the reported complaint could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.There were no non-conformances with respect to the manufacturing process.There were no associated nonconformity reports or deviations.The lenses were released according to specifications.The complaint history search revealed no other complaints for this production order number has been received.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a patient experienced a hyperopic surprise.The zcb00 10.5 diopter intraocular lens (iol) was explanted on (b)(6) 2016 and was replaced with the same model zcb00 lens, a larger 20.5 diopter.Patient's vision improved after iol exchange and patient is happy with surgery outcome.There was no incision enlargement, no vitrectomy was required.Visual acuity pre-op (pre-initial implant): sc (sans corrected) (20/40-2).Visual acuity post-op (post-initial implant): sc (cf) (counting fingers)pinhole: 20/70.Visual acuity post-op (post-replacement): sc (20/50).Treatment or prescription given by the doctor: besivance, lotemax gel, prolensa.

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6056188
• Report Number: 2648035-2016-01656
• Device Sequence Number: 10770350
• Product Code: HQL
• UDI-Device Identifier: 05050474531529
• UDI-Public: (01)05050474531529(17)180204
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/25/2016

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?: No
• Operator of Device: Physician
• Device Expiration Date: 02/04/2018
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2016
• Initial Report FDA Received Date: 10/25/2016
• 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