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

Model Number SOFTECHD+20.5

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 07/26/2022

Event Type  Injury  

Event Description

Lenstec received an email stating, iol exchange due to haze/cloudiness.

Manufacturer Narrative

Based on the assessment of the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Additionally, there have not been any other complaints from this batch.Furthermore, lenstec can also confirm that there have never been any confirmed lens-related cases of clouding, discoloration, or opacification of our hema lenses.Microscopic examination of the lens revealed that the haze/cloudiness seen were superficial, as it did not extend through the lens matrix.Lenstec's medical monitor is reviewing the case and a supplemental report will be provided once complete.

Manufacturer Narrative

Based on the assessment of the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Additionally, there have not been any other complaints from this batch.Furthermore, lenstec can also confirm that there have never been any confirmed lens-related cases of clouding, discoloration, or opacification of our hema lenses.Microscopic examination of the lens revealed that the haze/cloudiness seen were superficial, as it did not extend through the lens matrix.Lenstec's medical monitor reviewed the case and states the patient's extensive comorbidities are likely the source of the haze/cloudiness seen.

Event Description

Lenstec received an email stating, iol exchange due to haze/cloudiness.

• Brand Name: SOFTEC HD
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• 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: 15394116
• MDR Text Key: 299605735
• Report Number: 9613160-2022-00015
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369027311
• UDI-Public: 00844369027311
• 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,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2019
• Device Model Number: SOFTECHD+20.5
• Device Catalogue Number: SOFTEC HD
• Device Lot Number: 142846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2014
• 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