MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. I/A HP 20 GA 45 DEG SILICONE SLV TIP; PHACO ACCESSORY

Model Number	OPOIA2045D
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Manufacturer date is unknown.A device investigation, review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Phaco tip broke in the patient¿s eye was reported.A brief description from the surgery center indicated that the phaco tip it broke in the eye chamber while irrigation/aspiration (i/a) was being performed after the implantation of the intraocular lens (iol).The surgeon replaced the tip and surgery was successfully completed.Patient outcome was good.
Additional Manufacturer Narrative
H3: the irrigation/aspiration (i/a) tip was inspected under a microscope.The broken-off tip was not returned with the base, making a conclusive analysis difficult.No indication was found that the i/a tip was made improperly.The base was deformed and bulging.The bulge suggests compressive forces, indicating that the tip became weakened by bending.The wall thickness did not appear to be compromised on the inspected part, so bending the tip would have required significant force.The location of the deformation suggest that the break could have been caused by hitting the end of the tip against another object.It also could be caused by excessive force on the side of the tip or by a combination of these forces.This likely occurred before insertion in the eye, weakening the tip so that tip broke under the forces encountered inside the eye.This is the first complaint for this lot and the fifth complaint for this part number since distribution start date of (b)(6) 2018.Conclusion: the tip was broken off due to bending, which was most likely due to user handling.A review of records related to the device was reviewed and no anomalies were identified.Johnson & johnson surgical vision will continue to monitor this type of complaint.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: I/A HP 20 GA 45 DEG SILICONE SLV TIP
• Common Device Name: PHACO ACCESSORY
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10882724
• Report Number: 3006695864-2020-00507
• Device Sequence Number: 11486814
• Product Code: HQC
• UDI-Device Identifier: 05050474521049
• UDI-Public: (01)05050474521049(17)991231(10)097073
• Combination Product (Y/N): Y
• Initial Reporter Country: KR
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2020

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
• Operator of Device: Health Professional
• Device Model Number: OPOIA2045D
• Device Catalogue Number: OPOIA2045D
• Device Lot Number: 097073
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1