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

Model Number	ZCT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2017.Explant date: if explanted, give date: not applicable, as the lens remains implanted.However, there is a planned explant scheduled for (b)(6) 2017.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zct150 21.5 diopter intraocular lens (iol) was implanted in the patient's left eye (os) on (b)(6) 2017.Post-operatively, there was a surprise outcome with the astigmatic patient.There were several corneal measurements pre-operatively, which suggested a toric lens for the patient, but the patient had 1 - 1.5 diopters of cylinder in the opposite access.The patient's pre-operative visual acuity was 20/50 without correction and post-operatively vision was also 20/50 uncorrected.Visual acuity for both eyes pre-operatively were 20/20.Post-operatively, one week after surgery, the patient still complained of blurry vision and the manifest refraction had unexpected results.Pre-operative auto refraction results were +2.00 x -1.50 x 104 and post-operative refraction results were +0.75 x -1.50 x 10 with a best corrected visual acuity of 20/15.There is a planned explant scheduled for (b)(6) 2017 no additional information was provided.
Additional Manufacturer Narrative
Additional information received indicated that the lens was not explanted.After consulting with j&j medical affairs, the account decided that the best course for the patient was a rotation of the original intraocular lens.It was confirmed that no incision enlargement, vitrectomy or sutures were required for the rotation and there was no patient injury at any time reported.The following has been updated accordingly: (b)(4).Device evaluation: the product testing was not performed as the complaint devices were not returned for evaluation (the lens remains implanted).The reported complaint cannot be verified.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Historical data analysis: the search in complaint history revealed no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 7156213
• Report Number: 9614546-2017-01283
• Device Sequence Number: 63560
• Product Code: HQL
• UDI-Device Identifier: 05050474552173
• UDI-Public: (01)05050474552173(17)190902
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018
• Report Date (Section F): 01/01/2005

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: 09/02/2019
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U215
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 12/30/2017
• Supplement Report FDA Received Date: 08/23/2018
• 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
• Date Report Sent to FDA: 01/01/2005