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

Model Number PSCST30

Device Problems Break (1069); Crack (1135); Mechanical Jam (2983)

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

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

Weight and ethnicity: unknown, information not provided.If implanted, give date: not applicable as this is not an implantable device.  if explanted, give date: not applicable as this is not an implantable device.  all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the cartridge had a tear and the intraocular lens (iol) split.The lens advanced so far, but did not advance furthermore.There was patient contact only with the cartridge.The procedure was completed using another lens of same model and diopter.No further information available.

Manufacturer Narrative

Section d9.Device available for evaluation? yes.Returned to manufacturer on: nov.11, 2021.Section h3.Device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification revealed trace amounts of viscoelastic residue on the inside of the cartridge.Further inspection revealed a crack on the cartridge.The lens was visually inspected under magnification as well, which revealed viscoelastic residue on the optic body and haptics.The lens was cleaned, and a torn iol and lens damage was observed.The complaint issue cartridge crack could be confirmed; however, this may be attributed to an inadequate amount of ovd, suggested by the trace amounts of viscoelastic residue on the inside of the cartridge, it cannot be confirmed to be related to a manufacturing issue.The complaint issue lens damage could be confirmed; however, this may be attributed to handling during the return process, suggested by the fact that the lens was crushed in the lens insert, and cannot be confirmed to be related to a manufacturing issue.The complaint issue stuck in cartridge could not be confirmed.Therefore, no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that five additional complaint was received from this production order.Even though, four of these complaints are related to this complaint, no product deficiency was identified in any of these.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 12649521
• MDR Text Key: 277150228
• Report Number: 2020664-2021-07733
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(17)220202(10)CJ13736
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2022
• Device Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Device Lot Number: CJ13736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2021
• 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
• Treatment: LENS MODEL Z9002,SN: (B)(4).
• Patient Sex: Male