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

Age/date of birth, weight, ethnicity: unknown/not provided.If implanted, give date: not applicable, as the cartridge is not an implantable device.If explanted, give date: not applicable, as the cartridge is not an implantable device.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.Should additional information be received regarding this event the case will be reopened and processed accordingly.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported when inserting the intraocular lens (iol), they tried pushing the iol, and the pscst30 cartridge split at the tip and ripped the lens and haptics.The lens was not stuck in the cartridge and there was no patient injury.Another johnson and johnson lens with the same model and diopter size was implanted in the patient's ocular sinister (left eye).Patient post-op status was reported as doing fine.No further information is available.

Manufacturer Narrative

Additional information: device evaluation: product testing could not be performed because the product was not returned.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search of complaints revealed that four (04) additional complaint folders were found as part of this production order (po) number.Complaint 1 - no product investigation was created.Complaint 2 & 3 - product investigation is pending.Complaint 4 ¿ no product deficiency was identified conclusion: as a result of the investigation, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: upon further review, it was noted that in the initial mdr section h6, device codes device partially delivered, haptic damage, and iol torn were inadvertently not captured.Therefore, this supplemental filing is to correct the medical device problem codes there were was not originally captured.The following sections have been updated accordingly: section h6: medical device problem code: 1069 - haptic damage, 22920 - device partially delivered, 4008 - iol torn.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
• MDR Report Key: 11750434
• MDR Text Key: 255775877
• Report Number: 2648035-2021-07638
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(17)210923(10)CH14579
• Combination Product (y/n): N
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2021
• Device Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Device Lot Number: CH14579
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 04/29/2021
• Supplement Dates Manufacturer Received: 05/06/2021; 08/09/2021
• Supplement Dates FDA Received: 05/26/2021; 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: Z9002 SERIAL NUMBER: (B)(6).
• Patient Age: 73 YR