MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H10; INTRAOCULAR LENS

Model Number	CC4204A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	08/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Device evaluation: the lens was returned in liquid, in the lens vial.Visual inspection found no visible damage to the lens.(b)(4).
Event or Problem Description
The reporter indicated that, as the surgeon was implanting a cc4204a intraocular lens, diopter +18.5 into the patient's left (os) eye, he noticed that the incision was not large enough to implant the lens.The lens was removed in order to enlarge the incision and an alternate lens was successfully implanted.This occurred on (b)(6) 2018.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Corrected: the reporter indicated that the surgeon attempted to implant a cc4204a intraocular lens, diopter +18.5 into the patient's left (os) eye on (b)(6) 2018.The reporter states the lens touched the eye, the doctor felt the incision wasn't larger enough and pulled the lens from the eye.The incision was enlarged and a new lens was implanted.This occurred intraoperatively.Claim# (b)(4).

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7886302
• Report Number: 2023826-2018-01405
• Device Sequence Number: 2050245
• Product Code: HQL
• UDI-Device Identifier: 00841542102360
• UDI-Public: 00841542102360
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 09/25/2018; 11/05/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 10/17/2018; 11/06/2018
• 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: 68 YR