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

Model Number SOFTECI+22.5

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Toxic Anterior Segment Syndrome (TASS) (4469); Unspecified Eye / Vision Problem (4471)

Event Date 01/21/2021

Event Type  Injury  

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.The device remains implanted and the patient symptoms resolved.Lenstec can also confirm that there have never been any confirmed lens-related cases of clouding, discoloration or opacification of our hema lenses.There is no evidence to suggest that any aspect of this device was responsible for the reported inflammation.A supplemental report will be submitted once a medical monitor assessment is complete.

Event Description

Lenstec received an email stating " the surface of softec i crystal appears similar to ground glass, with a layer of white material attached.After implantation of the crystal, the patient appears inflammation, and the inflammation is severe.Two or three days after the operation, the white material attached to the crystal surface disappeared, and the inflammation remained.The phemomenon of crystal has appeared many times".

Event Description

Lenstec received an email stating " the surface of softec i crystal appears similar to ground glass, with a layer of white material attached.After implantation of the crystal, the patient appears inflammation, and the inflammation is severe.Two or three days after the operation, the white material attached to the crystal surface disappeared, and the inflammation remained.The phenomenon of crystal has appeared many times".

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.The device remains implanted and the patient symptoms resolved.Lenstec can also confirm that there have never been any confirmed lens-related cases of clouding, discoloration or opacification of our hema lenses.There is no evidence to suggest that any aspect of this device was responsible for the reported inflammation.

• Brand Name: SOFTEC I
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 11388720
• MDR Text Key: 234747224
• Report Number: 9613160-2021-00002
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369029544
• UDI-Public: 00844369029544
• Combination Product (y/n): N
• PMA/PMN Number: P090022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

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
• Device Operator: Health Professional
• Device Model Number: SOFTECI+22.5
• Device Catalogue Number: SOFTEC I
• Device Lot Number: SB09492
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1