MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNFOLDER SILVER LENS, GUIDE, INTRAOCULAR

Model Number PSCST30

Device Problems Crack (1135); Inaccurate Delivery (2339); Mechanical Jam (2983); Material Split, Cut or Torn (4008)

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

Event Date 09/28/2021

Event Type  malfunction  

Manufacturer Narrative

Weight, ethnicity: unknown/asked but unavailable. Lot number: unknown, as information was not provided. Expiration date: unknown as product lot number was not provided. Udi number: a complete udi number is unknown as product lot number was not provided. If implanted; give date: n/a (not applicable). The cartridge is not an implantable device. If explanted; give date: n/a (not applicable). The cartridge is not an implantable device. Device manufacture date: unknown, as the lot number was not provided. Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified. Manufacturing record review: the manufacturing record could not be reviewed since the lot number was not provided. Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.

Event Description

It was reported while inserting the intraocular lens (iol) in the left eye, it got 1/3 of the way when the front haptic and iol got stuck in the cartridge. The surgeon backed the iol off and the lens tore. After the surgeon looked at the cartridge, it was observed cracked. Another johnson & johnson lens (same model and diopter) was implanted as a replacement. There was no vitrectomy, incision enlargement, or sutures required. There was no patient injury. The patient is doing fine post-operatively. Through follow-up, it was learned that the surgeon was attributing the event to the cartridge cracking. The tip of the cartridge was not damaged. No further information was available.

• Brand Name: UNFOLDER SILVER
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12682419
• MDR Text Key: 278110802
• Report Number: 2020664-2021-07855
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial