MAUDE Adverse Event Report: LENSTEC BARBADOS INC. SOFTEC HD PLI; INTRAOCULAR LENS

Model Number	SOFHDPLI+20.0D AND PLITIP1645 KIT
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A full audit of all batch documentation relating to the production of the device was performed.The audit concluded that all procedures in manufacturing and packaging of the device had been conducted correctly.Batch reconciliation was 100.0%.Based on the assessment of our batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.
Event or Problem Description
Lenstec received an email stating " the lens was broken when doing the surgery, the broken lens was explanted and a new iol was implanted.Removal of the lens requires a larger incision and damages the patients corneal endothelium, the patients corneal edema persisted for 20 days after the surgery".Additional information provided stated that " the patient is recovering well now, no pharmaceuticals administered".
Additional Manufacturer Narrative
A full audit of all batch documentation relating to the production of the device was performed.The audit concluded that all procedures in manufacturing and packaging of the device had been conducted correctly.Batch reconciliation was 100.0%.Additionally, no other complaints have been received from this batch.The investigation of the device indicates that the damage on the lens was due to surgical manipulation and removal from the eye (lens was cut).Furthermore, all lenstec's devices are 100% inspected and if damages were present the device would have been rejected.Moreover, lenstec ensures though previous validations, that if the instruction for use are followed, the lens will be implanted without damage.
Event or Problem Description
Lenstec received an email stating " the lens was broken when doing the surgery, the broken lens was explanted and a new iol was implanted.Removal of the lens requires a larger incision and damages the patients corneal endothelium, the patients corneal edema persisted for 20 days after the surgery".Additional information provided stated that " the patient is recovering well now, no pharmaceuticals administered".

• Brand Name: SOFTEC HD PLI
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 11942113
• Report Number: 9613160-2021-00014
• Device Sequence Number: 11818895
• Product Code: HQL
• UDI-Device Identifier: 00844369002516
• UDI-Public: 00844369002516
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 08/25/2025
• Device Model Number: SOFHDPLI+20.0D AND PLITIP1645 KIT
• Device Catalogue Number: SOFTEC HD PLI
• Device Lot Number: SB10208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1