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

Model Number	Z9002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	12/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant and explant date: : if implanted or explanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.(b)(4).Device evaluation: the product testing could not be performed because the product was not returned for evaluation.The complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated.The product was manufactured and released according to specifications.A search on complaints related to this production order was conducted.The search revealed no other complaints have been 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 the manufacturer has been submitted.
Event or Problem Description
It was reported that a z9002, 17.0 diopter intraocular lens (iol) was fully inserted in the left eye (os) of a patient and removed as there was not enough capsule to support the lens.It was indicated that there was no product issue.A vitrectomy and incision enlargement were required and four (4) sutures were placed.The surgery was completed successfully and an anterior chamber lens was implanted.There was no patient injury reported.No further information was provided.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7264205
• Report Number: 2648035-2018-00233
• Device Sequence Number: 10953528
• Product Code: HQL
• UDI-Device Identifier: 05050474530638
• UDI-Public: (01)05050474530638(17)220328
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2018

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: 03/28/2022
• Device Model Number: Z9002
• Device Catalogue Number: Z900200170
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PSCST30 CARTRIDGE, LOT# CC08496
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR