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

Lot Number 232910

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2023

Event Type  Injury  

Manufacturer Narrative

Based on the review of the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the devices were conducted correctly.Additionally, we have not received any other complaints from these batches.Based on the investigation of both devices, the damage to the haptic suggest that the lens was probably handled whilst in a dehydrated state.Lenstec recommends users to follow the details noted in the instruction for use which states that the lens should not be held out of the saline solution for no more than two minutes before implantation.The damage to the optic of both devices was probably cut to facilitate the removal of the lens from the eye.Additionally, lenstec is unable to comment on the compatibility of the softec hd lens and the cm10340 platinum injector that was used.

Event Description

Lenstec, inc.Received an email notification stating "haptic tore during insertion.The incision was enlarged to remove the lens.Cm10340 platium injector was used.Another lens was implanted.".

• Brand Name: SOFTEC HD
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, BB170 92,; BB BB17092,
• Manufacturer (Section G): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• Manufacturer Contact: jimmy chacko ; 1765 commerce ave. n.; st. petersburg, FL 33716 ; 7275712272
• MDR Report Key: 18547483
• MDR Text Key: 333315390
• Report Number: 9613160-2024-00003
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369027335
• UDI-Public: 00844369027335
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 232910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2023
• Date Manufacturer Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2023
• 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