MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNFOLDER PLATINUM 1 SERIES; LENS, GUIDE, INTRAOCULAR

Model Number 1MTEC30

Device Problems Crack (1135); Use of Device Problem (1670); Inaccurate Delivery (2339)

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

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

Age, weight, and ethnicity: unknown/asked but unavailable.Lot number: unknown, information not provided.Expiration date: unknown, information not provided, as the lot number was not provided.Udi number: a partial udi number is known, as the lot number was 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.Device manufacture date: unknown, information not provided, as the lot number was not provided.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the intraocular lens (iol) did not load correctly and the cartridge had a defect in it.Additional information received revealed that the tip of the cartridge had a fork in it.The cartridge had a split near the tip which was not seen until it was seen in the microscope.Due to this, the lens wrapped around the plunger instead of curling up when the plunger was applied to insert the lens into the patient's operative eye.The tip of the lens was inserted into the eye, however, the lens inserter was pulled out before completely pushing the lens into the eye as the problem was noticed then.No additional intervention was required and the procedure was completed using a different lens and cartridge.No further information was available.

Manufacturer Narrative

Corrected data: through follow-up, it was learned that the model number of the suspect cartridge to be 1mtec30 and not pscst30 as reported initially.The following sections have been updated to reflect the 1mtec30 device identifiers: section d1: brand name: unfolder platinum 1 series.Section d4: model number: 1mtec30.Section d4: catalog number: 1mtec30.Section d4: unique identifier (udi) number: (b)(4).Unknown (partial udi number is known, as the lot number was not provided).Section g4: pma/510(k) number: k081545.Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: aug 25, 2021.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection of the cartridge tip under magnification revealed only trace amounts of viscoelastic residue and a cracked cartridge tip.The complaint issues loading issues and delivery issues could not be confirmed.The complaint issue cartridge tip crack was confirmed; however, this can be attributed to handling, the lack of viscoelastic residue in the cartridge would suggest that not enough was used during implanting, which is consistent with causing cartridge tip damage.Therefore, the complaint issue cannot be confirmed to be due to manufacturing and no product deficiency could be identified.Manufacturing record review: the manufacturing records for the product were not reviewed.Since lot number was not available, neither a manufacturing record evaluation nor complaint occurrence/history for the production order were possible.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 PLATINUM 1 SERIES
• 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: 12298536
• MDR Text Key: 265806693
• Report Number: 2648035-2021-08257
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(10)UNKNOWN
• Combination Product (y/n): N
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

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 Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 09/16/2021
• Supplement Dates FDA Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZCU150 LENS SERIAL NUMBER: (B)(4)