MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

Model Number DIB00

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 04/25/2023

Event Type  malfunction  

Event Description

It was reported that the surgeon implanted three preloaded intraocular lenses (iols) on (b)(6) 2023, and in each case the trailing haptic stuck to the optic and a second instrument was required to unstick it.The surgeon used a straight connor wand and a second bent connor wand and used both to squeeze the bulb of the haptic and lift it off the optic and then it would release.The surgeon reported that it takes about 10 seconds.In these cases, the surgeon noted that it is more than just a "tap" ¿ it is mechanically lifting the haptic off the optic.The surgeon noted that "it is not a big deal" for the surgeon, but it does add a few seconds to the case.No further information was provided.

Manufacturer Narrative

Section d6b: if explanted, give date: not applicable, as the lenses remain implanted.Section d4: model number: the surgeon noted the issue was with preloaded eyhance iols, the exact model(s) is unknown.Section d4: serial number: unknown, information was requested but not provided.Section d4: catalog number: a complete catalog number is unknown, as the serial number was not provided.Section d4: expiration date: unknown, as the serial number was not provided.Section d4: unique identifier (udi) number: unknown, as the serial number was not provided.Section h4: device manufacture date: unknown, as the serial number was not provided.Section h3-other (81): the device was not returned for evaluation, as it remains implanted, and the serial number for this device is unknown/not provided; therefore, no further product investigation can be performed.Should any further relevant information become available a supplemental medwatch will be filed.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16955941
• MDR Text Key: 316444138
• Report Number: 3012236936-2023-01270
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: UNK-DIB00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2023
• 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
• Patient Sequence Number: 1