MAUDE Adverse Event Report: STAAR SURGICAL COMPANY COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE IOL; INTRAOCULAR LENS

Model Number	CQ2015A
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	04/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient code: (b)(4) secondary surgery, lens exchange.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a cq2015a, +19.0 diopter, intraocular lens into the patient's left eye (os) on (b)(6) 2018.During surgery, the sac of the eye was dropped.The sac was damaged during phaco and the lens would not center into place.The eye was also damaged while lens was trying to be inserted.The lens was removed intraoperatively.There was damage to the eye, so an anterior vitrectomy was done.Afterwards the surgeon inserted an anterior chamber lens.
Additional Manufacturer Narrative
The reporter indicated that the surgeon implanted a cq2015a intraocular lens of +19.0 diopter into the patient's left eye (os) on (b)(6) 2018.During surgery the sac of the eye was dropped.The sac was damaged during phaco and the lens would not center into place.The reporter stated that the injury was not product related.The eye was also damaged while the lens was trying to be inserted.The lens was removed intraoperatively.There was damage to the eye so an anterior vitrectomy was done.Afterwards the surgeon inserted an anterior chamber lens.(b)(4).

• Brand Name: COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7481809
• Report Number: 2023826-2018-00626
• Device Sequence Number: 1705117
• Product Code: MTA
• UDI-Device Identifier: 00841542101967
• UDI-Public: 00841542101967
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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: 12/31/2018
• Device Model Number: CQ2015A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 07/02/2018
• 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
• Patient Age: 72 YR