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

Model Number	CC4204A +24.0
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	12/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt info: unk.Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.(b)(4).Work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a cc4204a, +24.0 diopter, intraocular lens into the patient's eye on (b)(6) 2018.Within the initial surgery, the surgeon noted the lens did not look right and the lens was removed and replaced with another manufacturer's lens.It was reported that patient's capsule was compromised, not sure if it was because of lens.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional data: the reporter indicated that the surgeon implanted a (b)(4) +24.0 diopter intraocular lens into patient's right eye (od) on (b)(6) 2018.The lens was damaged during loading and it was reported that the tear was noticed during insertion (lens in anterior chamber).The reporter stated there was inferonasal capsular break and an anterior vitrectomy was performed.A competitor's replacement lens was then implanted.The problem was resolved.Device evaluation: lens was returned dry, in lens vial with a ziploc bag.There was clear surgical residue on product.Visual inspection found the haptic torn and presence of residue on lens surface.(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: 8256678
• Report Number: 2023826-2019-00124
• Device Sequence Number: 1833710
• Product Code: HQL
• UDI-Device Identifier: 00841542102476
• UDI-Public: 00841542102476
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

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: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: CC4204A +24.0
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 02/25/2019
• 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