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

Model Number CQ2015A

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vitrectomy (2643); No Code Available (3191)

Event Date 04/02/2018

Event Type  Injury  

Manufacturer Narrative

Patient code: (b)(4) secondary surgery, lens exchange.(b)(4).

Event 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.

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
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 7481809
• MDR Text Key: 107187796
• Report Number: 2023826-2018-00626
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542101967
• UDI-Public: 00841542101967
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 07/02/2018
• Supplement Dates FDA Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR