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

Model Number PSCST30

Device Problems Break (1069); Crack (1135); Difficult to Advance (2920); Material Split, Cut or Torn (4008)

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

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

Weight and ethnicity: unknown/ not provided. If implanted, give date: not applicable, as lens was removed/replaced during the same procedure. If explanted, give date: not applicable, as lens was removed/replaced during the same procedure. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.

Event Description

It was reported that when they were trying to insert the intraocular lens (iol) into the patient's right eye, the unloader (cartridge) split at the tip and ripped the lens and haptics. It was stated that the patient was doing fine. No other information was provided.

• 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 ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 11751154
• MDR Text Key: 265469602
• Report Number: 2648035-2021-07659
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(17)210923(10)CH14579
• 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 faci

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/23/2021
• Device Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Device Lot Number: CH14579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 05/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial